Sleep apnea and anti-snoring system

ABSTRACT

A sleep apnea treatment/anti-snoring device optionally having controlled positive air-flow using a micro-blower to maintain an individual&#39;s upper airway unobstructed (pharynx area). Optionally the device includes a lower jaw mandibular advancement component. The device has built-in sensors, microprocessor and other items required for data acquisition and transfer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/269,331, filed on Dec. 18, 2015. The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The teachings are directed towards sleep apnea/anti-snoring devices andmore particularly to a cordless and tubeless hybrid sleepapnea/anti-snoring devices for reducing and measuring sleep apnea andsnoring.

BACKGROUND

Obstructive sleep apnea (OSA) is a Sleep disorder with partial orcomplete cessation of breathing during one's sleep. This sleep disorderis currently treated by methods such as a surgery, oral appliancetherapy, negative pressure to pull soft palate and tongue forward,implantable devices that keep the airway open during sleep bystimulating the hypoglossal nerve, strips for nose for expiratorypositive airway pressure, Positive Air Pressure (PAP) therapy or acombination involving several methods. PAP therapies are also employedto treat other medical and respiratory disorders, such as Cheynes-Stokesrespiration, congestive heart failure, and stroke. A common PAP devicecomprises a flow generator (e.g., a blower) that delivers gas viadelivery conduit (hollow tube) to an individual interface. It is alsoknown to deliver the PAP as a continuous positive airway pressure(CPAP), a variable airway pressure, such as bi-level pressure (Bi-PAP)that varies with the individual's respiratory cycle or an auto-titratingpressure (APAP) that varies with the monitored condition of theindividual. Nasal, oral-nasal and full face masks are common interfacesutilized for delivering PAP to the individual's airway.

These masks can be uncomfortable due to improper fit, tight straps tohold mask in place, skin irritation at points of contact, dryness ofthroat cause claustrophobia, excessive PAP pressure and are a majorfactor in individual therapy non-compliance. Also the PAP machines canbe noisy. Studies show individual non-compliance for PAP therapy from 29to over 83%.

Obstructive sleep apnea (OSA) is a Sleep disorder with partial cessation(hypopnea) or complete cessation (apnea) of breathing during one'ssleep. This sleep disorder is diagnosed and analyzed by a technicianmonitored overnight sleep study in a sleep laboratory setting(Polysomnography or PSG) with multiple physiological parameters and morerecently by Home Sleep Testing devices with limited parameters.

The federal Center for Medicare and Medicaid Services (CMS) has providedguidance for various types of sleep studies based on number ofparameters and whether study is attended by Sleep technician or isunattended. A brief summary of the classification system for sleepstudies based on these guidelines is provided below.

Most of the current Home Sleep Testing (HST) devices are worn on chestwhile current device of invention is only device which is worn in mouth.It is very comfortable, convenient, small in size and provide for moreinformation due to proximity of several sensors to nose and mouth whereactual sleep disturbances events should be measured.

Type I HST devices using in attended sleep studies performed in a sleeplab and monitored by a sleep technician with full sleep staging (i.emonitoring the transition through the various sleep stages). Typically,Type I devices include the following channels (parameters): EEG(electroencephalogram), EMG (electromyogram —chin and Limb), EOG(electrooculogram), respiratory airflow (with oronasal flow monitors),respiratory effort (Thorax and Abdomen), oxygen saturation (oximetry),ECG (electrocardiography), snoring sounds, and body position—additionalchannels for CPAP/Bi PAP levels, CO2, pH, pressure etc.

Type II Home sleep test (HST) devices use a portable monitor, performedwithout any sleep technician monitoring the study, with at least 7channels or parameters. Type II devices typically include at the veryleast the following Parameters: EEG, EOG, ECG/heart rate, EMG, Airflow,Respiratory effort, Oxygen saturation. Type III Home sleep tests (HST)use a portable monitor unattended with a minimum of 4 channels. Type IIIdevices usually include the following parameters: 2 respiratorymovement/airflow, 1 ECG/heart rate, 1 oxygen saturation. Type IV Homesleep test (HST) with Type IV portable monitor, unattended with aminimum of 3 channels. Type IV devices must allow parameters that allowdirect calculation of an AHI (Apnea Hypopnea Index) or RDI (RespiratoryDisturbance Index) as the result of measuring airflow orthoracoabdominal movement. The RDI is defined as the average number ofrespiratory disturbances.

Alternately devices that record other information to derive AHI or RDImust be approved by CMS through the review of published peer reviewedmedical literature. It is very expensive to perform the traditionalattended PSG sleep studies in sleep labs (Type I) to diagnose for OSA.Patients have difficulty getting to sleep in a unfamiliar surroundingwith various wires connected to their limbs and head and beingcontinuously watched and monitored. This created a need for a simplerand cheaper way to diagnose for OSA and led to the development ofportable sleep monitors—Home Sleep Testing machine (HST) complying withthe CMS guidelines and offering results comparable to that of PSG in ahome setting.

SUMMARY

The teachings relates to oral or nasal or a combination of oral andnasal device for treatment and diagnosis of obstructive sleep apnea andsnoring; having microprocessors and sensors, can include the followingconfigurations and all devices are with or without mandibularadvancement (MAD): Oral Device having micro-blowers and controlmodule—positive airflow (PAP) device; Oral Device having micro-blowersand control module—auto control positive airflow (Auto PAP) device andproprietary algorithm for auto adjustment of pressure and/or flow rate;Oral/Nasal Device having micro-blowers with positive airflow (PAP orAPAP) utilizing nasal passage for air delivery; Oral Device withoutmicro blower and with or without microprocessor, sensors and dataacquisition system; and the above oral devices with capability fortesting sleep apnea known as HST or OOCST (out of center sleep testing)diagnostic PAP device and capability to treat OSA.

All above configurations according to the teachings within thisapplication can be without mandibular advancement (MAD) and can beprovided with upper mouth piece only (i.e. without the lower mouthpiece) or with lower mouth piece only (i.e. without the upper mouthpiece). All above devices can be customized or non-customized by usingcasting, 3d printing or boil and bite techniques.

According to the present teachings, an oral sleep apnea treatment deviceselectively engagable with a patient's lips and teeth is presented. Theoral sleep apnea treatment device includes a front hollow housingdefining a first through passage, said front hollow housing having anexterior surface configured to engage the patient's lips. A mouthpieceis provided having an exterior surface defining a tooth engaging surfaceand defining second and third through passages, each defining anaperture disposed adjacent to the adjacent to the retromolar pad memberswhen engaged with the patient's teeth. A pressure and/or air flowgenerating device in the form of a blower is disposed within the firstthrough passage. The pressure and/or air flow generating deviceconfigured to create an airflow through the second and third passage andadjacent the retromolar pad members.

According to another teaching, the device has a battery disposed withinthe front hollow housing, said battery being electrically coupled to thepressure and/or air flow generating device.

According to another teaching, the afore mentioned device has acontroller configured to regulate electrical power supplied to thepressure and/or air flow generating device.

According to another teaching, in the afore mentioned device the fronthollow housing is selectively engageable to the mouthpiece.

According to another teaching, the afore mentioned device is formedusing one of additive manufacturing, injection molding, and blowmolding.

According to another teaching, the afore mentioned device the mouthpieceis injection over-molding with an elastically deformable, low durometermaterial.

According to another teaching, the afore mentioned device further hasfirst and second members having member defining a u-shape said first andsecond members defining the defining second and third through passages,and a plurality of flanges disposed between the first and second membersand said plurality of flanges engaging a tongue.

According to another teaching, the afore mentioned the mouth piece hasfirst and second u shaped components, the first and second u-shapedmembers defining the second and third through passages.

According to another teaching, the afore mentioned device further has acontrol module in the front hollow housing, wherein the control moduleis coupled to a plurality of sensors, the control module configured toprovide a signal to control operation of the pressure and/or air flowgenerating device.

According to another teaching, the afore mentioned device includes aplurality of sensors which can be one of a pressure sensor, an airflowsensor, temperature sensors, sound sensor, an accelerometer, and a pulseoximeter According to another teaching, the afore mentioned devicewherein the control module has a closed loop control system and awireless communication module.

According to another teaching, the afore mentioned devices furtherhaving a mandibular advancement device.

According to another teaching, the afore mentioned device furtherincluding a nostril tubes in connection to the front hollow housing to anasal passage.

According to the present teachings, an home sleep test device isprovided which is selectively engagable with a patient's lips and teeth.The home sleep test device includes a front hollow housing defining afirst through passage, the front hollow housing having an exteriorsurface configured to engage the patient's lips. A mouthpiece isprovided having an exterior surface defining a tooth engaging surfaceand defining second and third through passages, each defining anaperture disposed adjacent to the adjacent to the retromolar pad memberswhen engaged with the patient's teeth. A data acquisition system withinthe first through passage. The data acquisition system is configured tomeasure an airflow through the second and third passage and adjacent theretomolar pad members.

According to another teaching, the device has a battery disposed withinthe front hollow housing, said battery being electrically coupled to thecontroller.

According to another teaching, in the afore mentioned device the fronthollow housing is selectively engageable to the mouthpiece.

According to another teaching, the afore mentioned device is formedusing one of additive manufacturing, injection molding, and blowmolding.

According to another teaching, the afore mentioned device the mouthpieceis injection over-molding with an elastically deformable, low durometermaterial.

According to another teaching, the afore mentioned device further hasfirst and second members having member defining a u-shape, said firstand second members defining the defining second and third throughpassages, and a plurality of flanges disposed between the first andsecond members and said plurality of flanges engaging a tongue.

According to another teaching, the afore mentioned the mouth piece hasfirst and second u shaped components, the first and second u-shapedmembers defining the second and third through passages.

According to another teaching, the afore mentioned device further has acontrol module in the front hollow housing, wherein the control moduleis coupled to a plurality of sensors, the control module configured toprovide a signal to control operation of the pressure and/or air flowgenerating device.

According to another teaching, the afore mentioned device includes aplurality of sensors which can be one of a pressure sensor, an airflowsensor, temperature sensors, sound sensor, an accelerometer, and a pulseoximeter.

According to another teaching, the afore mentioned device wherein thecontrol module has a closed loop control system and a wirelesscommunication module.

According to another teaching, the afore mentioned devices furtherhaving a selectively adjustable mandibular advancement device

The teachings additionally relate to device designs and functioning ofdevice manufacturing methods, and materials for single piece, micro,tubeless, cordless, anti-snoring (AS)/sleep apnea treatment (SA) deviceswhere airflow from the front of the mouth is directed from the device tothe back of the mouth, bypassing the soft tissues, palates, tongue etc.This flow can be directly to the oropharynx or laryngopharynx area, withor without use of micro-blowers (and with or withoutmicroprocessor/sensors in both cases). The device can be attached to theupper arch (teeth) or the lower arch (teeth) or to both arches. Thedesign of the device allows for simultaneous nose and mouth breathing.

The device can be non-customized or customized for the individual.Air-flow is directed to the oropharynx area (throat area) from the mouthopening (lips area) using a front hollow housing and hollow tubes orother hollow shapes passageways attached to inner mouthguard bypassingsoft tissues. In case of standard CPAP configuration, air flow at apredetermined air flow rate and pressure is supplied. In case of an AutoPAP device, the pressure and airflow is continuously adjusted as perneed using micro fan(s), sensors and microprocessor with firmware(algorithm). In addition to an auto continuous positive air pressure(Auto CPAP) or non-auto continuous positive air pressure (CPAP)controlled mechanism, the oral device can also bring lower jaw forward(mandibular advancement device—MAD), increasing air passage, furthermitigating OSA and snoring.

This hybrid device is referred to herein as a single piece Oral CPAPwith MAD device. In all above concepts, the device has the capability torecord data within the system using a micro-SD card or to transfer datawirelessly to mobile devices or to cloud using Bluetooth to permit livemonitoring of the medical condition of the individual and treatmentcompliance. The device can record data (air flow rate, respiratoryefforts, oxygen saturation, pressure, temperature, snoring pattern, andposition during sleep) which can be used to determine sleep parameterssuch as AHI (Apnea/Hypopnea) index, SpO2, snoring level, breathingvariation etc., using proprietary algorithm.

The afore mentioned devices according to the present teachings can becontrolled by preprogrammed algorithms or by wirelessly updating withmobile device of parameters such as pressure, flow rate, mode ofoperation etc.

The afore mentioned devices according to the present teachings can alsoutilize active noise cancellation techniques and passive methods such asspecific sound insulating/absorbing materials to reduce the noise fromthe operation of the device.

The afore mentioned devices according to the present teachings can alsoincorporate features for tongue movement control such as preventing itfrom falling to the back of mouth and creating obstruction to the airway passage.

The afore mentioned devices according to the present teachings can bewithout micro blowers (or may be also without hollow tubes) can also beused as diagnostic sleep apnea device such as Home Sleep Study (HST)device. The sensors to measure air flow directly or differentialpressure to measure the airflow while breathing (air flow limitation tocalculate AHI index); a pulse oximeter to measure SpO2, heart rate andtemperature; a position sensor (tilt sensor) to indicate position ofbody while at sleep, Sound sensor to measure breathing variation andsnoring; miniature video camera mounted on the mouthguard to takepictures of inside of mouth during sleep and a processing unit tocapture and analyze these parameters to provide a comprehensive sleepstudy report for a type 3 and other types HST device. These parametersare captured on a memory card built into the unit or wirelesslytransferred using Bluetooth, wifi, cloud or other similar technologies.

The afore mentioned devices according to the present teachings can beformed of two pieces: a front hollow housing (in which micro fan(s),sensors, microprocessors etc. are inserted after manufacturing) and aninner mouth piece with hollow air passage way. These pieces have snapfit and easy unsnap fit features.

The afore mentioned devices according to the present teachings can beformed of a plurality of processes. For example, the front hollowhousing with is made by injection molding, while hollow passage way forinner mouthpiece can be achieved by. Multi-step process: separatelyinjection mold partial hollow tube followed by bonding these two piecesto create hollow passage way in inner mouth piece; one step injectionmolding process with multi cavities and rotating tool; water or gasinjection molding to achieve hollow air passage way; and lost core foaminjection molding.

The afore mentioned devices according to the present teachings can beboth non-customized and customized devices are manufactured by similarprocesses as described above except for customizations (to fit the teethperfectly) is achieved by processes such as 3D printing (hard orhard/soft materials), “boil and bite” concept and micro-cellular foaminginjection molding processes.

The afore mentioned devices according to the present teachings can bringairflow from the front of the mouth to back of the throat (pharynx area)and can be combined with mandibular advancement (bringing the lower jawforward) to further assist in eliminating or reducing snoring and sleepapnea, referred to herein as PAP-MAD without micro-blower (with orwithout microprocessor and sensors) or PAP-MAD with micro-blower(s) andmicroprocessor and sensors or Auto-CPAP/MAD with micro-blower(s) havingsensors/microprocessor and closed loop control system and algorithm tohave comfortable pressure/air flow change during sleep.

According to another teaching, the afore mentioned structures can beused for oral or nasal or a combination of oral and nasal device as HomeSleep Testing (HST) device for the diagnosis of obstructive sleep apnea(OSA) and snoring. The HST can include having microprocessors andsensors.

The HST unit for standard OSA testing without mandibular advancement(MAD) can be provided with upper mouth piece only (i.e. without thelower mouth piece) or with lower mouth piece only (i.e. without theupper mouth piece).

According to an alternate teaching, the HST unit can include mandibularadvancement (MAD) to validate specific mandibular advancement settingand treatment of sleep apnea with or without innovative oral CPAP sleepapnea device or current CPAP device.

According to an alternate teaching, the HST unit can be used inconjunction with CPAP for determining the efficacy of a pressuresetting.

According to an alternate teaching, the HST unit can device as sleepapnea diagnostic as well as treatment device: In addition to deviceperforming as diagnostic tool (as Home Sleep Testing (HST) or Out ofcenter Sleep Testing (OOCST) for detecting OSA, the same device can alsobe used as sleep apnea treatment and/or anti-snoring device.

According to an alternate teaching, the HST unit can be fitted with amix of sensors to measure air flow; SpO2 (oxygen saturation in blood),heart rate (beats/min) and respiratory effort. These parameters would besufficient to perform a sleep study conforming to the guidelines by CMSor AASM for a Type III or Type iV study. Additional sensors can beincluded to measure temperature; body positions while at sleep, Sound(breathing) variation and snoring, Single channel ECG (heart), EEG forbrain activity etc.

Actual sleep time is not measured by current HST devices while in oneembodiment the device can have built-in sensors or wirelesslycommunicating sensors like heart rate, breathing monitoring, positionsensor for body movement during sleep, temperature along withproprietary algorithm helps in measuring actual (true) sleep time whichis very important for accurate (true) AHI number, a measure of severityof sleep apnea.

In one embodiment, the device would be fitted with a differentialpressure sensor to measure airflow and pressure (or alternately with aPVDF calibrated strip), a novel pulse ox sensor from lips for oxygensaturation and heart rate (alternately could be a standard pulseoximeter with Bluetooth capability), and a photophlethysmographic (PPG)sensor to measure respiratory effort (alternately could be a standardRIP belt to acquire the same parameter). All these parameters would becontinuously acquired and stored on a memory SD card built into the unit(device) or wirelessly transferred using Bluetooth, wi-fi, cloud orother similar technologies to a mobile device or to cloud based server.This data can then be analyzed by automated computer algorithms forepisodes of breathing irregularities while sleeping—such as apneaic orhypopneaic events and summarized to provide AHI/RDI information. The RDIis defined as the average number of respiratory disturbances. The devicecan be controlled wirelessly using mobile devices.

In another embodiment, the device can be enhanced by addition of soundsensor to measure breathing patterns and snoring variation, thermistorfor temperature of air flow and breathing pattern, miniature videocamera mounted on the mouthguard to take pictures of inside of mouthduring sleep and a processing unit to capture and analyze theseparameters to provide a far more comprehensive sleep study reportcompared to the Type III or Type IV HST devices.

Both of above embodiments can be adapted to validate MandibularAdjustment (MAD) setting by providing oral component with mandibularadjustments (lower jaw advancement) in specific fine increments.

Also the device of present invention can be concurrently used with CPAPand validate efficacy of pressure setting for the CPAP treatment.

DRAWINGS

FIGS. 1A to 1I depict various embodiments of a sleep apnea treatment oranti-snoring device attached to upper arch with hollow front housing andhollow side tubes (with or without microprocessor/sensors attached tofront hollow housing) to bring air at the end of the throat (pharynx)area according to the present teachings;

FIG. 1J depicts different cross sections of device—from front of thehousing to end of inner piece (oropharynx area) according to the presentteachings;

FIG. 1K shows further cross section at the center of device as per FIG.1I cross section;

FIG. 1L shows further cross section at the center of device as per FIG.1I cross section FIG. 1M shows the device with cross section areas to betaken for further figures and FIG. 1N depict one cross section of deviceas per FIG. 1M;

FIG. 1O shows the next cross section as per FIG. 1M;

FIG. 1P depicts the next cross section as per Figure;

FIGS. 1S-1Y represent various views of the device shown in 1O.

FIGS. 1Q and 1R further depict the cross sections to the presentteachings;

FIG. 2A to 2C depict a sleep apnea or anti-snoring device with bothupper and lower arches, where the upper arch comprises a curved centerhollow passageway designs from front of mouth other than hollow tube tokeep the tongue down while delivering airflow directly to theoropharynx/throat area according to the present teachings;

FIG. 2D shows hollow tube or hollow passageway design according to FIG.2 having a lower portion rotated with respect to an upper portion.

FIG. 2E shows an end view of the hollow tube or hollow passage waydesign shown in FIG. 2D;

FIGS. 3A and 3B depict a sleep apnea or anti-snoring device withdifferent designs of strips with two sided adhesive buttons or tapes tokeep the individual's tongue forward while still allowing tongue side toside movement according to the present teachings;

FIGS. 4A-4E depict conventional CPAP single piece oral sleep apneatreatment device with micro-blower(s) for continuous positive airflowwith microprocessors and sensors according to the present teachings;

FIGS. 5A-5D depict a variety of suitable micro-blowers for use with theteachings;

FIGS. 6A and 6B depict an Auto CPAP (APAP) device with a miniaturecontrol module inserted in hollow housing having micro-blower(s) andsensors and microprocessor (micro-chip) etc.;

FIGS. 6C and 6D depict micro fan(s) is mounted vertical, blowing the airstraight into housing and hollow tubes. FIG. 6D Show that micro fan(s)can be mounted horizontal and control module can be mounted verticallyto each according to the present teachings;

FIG. 7A depict an CPAP or Auto-CPAP (APAP) control module comprisingvarious items inserted in the housing of the device;

FIG. 7B depicts a schematic of the data flow and control moduleaccording to one embodiment of the teachings;

FIG. 8A depicts current mandibular advancement device (MAD) and FIG. 8Bdepicts a combination micro, tubeless, maskless, single piece Oral CPAPdevice with mandibular advancement capability (Hybrid PAP-MA Oral Deviceor Hybrid APAP-MA Oral Device);

FIG. 9 depicts one embodiment of a nasal/oral device with or without theMAD CPAP Device;

FIG. 10 depicts thin plastic membrane which depresses the upper arch ofmouthguard (at the end, throat area) which expands and stays expandedduring air flow from micro blower, stopping soft palates to collapse,allowing more open airway passage;

FIG. 11 depicts exploded view of separate pieces of device to bemanufactured;

FIG. 12 depicts various flows schemes for manufacturing methods for aCustomized, single piece, micro oral PAP or APAP device;

FIGS. 13A-13D depict a customized, single piece, micro oral PAP devicemade by a “Boil and Bite” manufacturing process;

FIGS. 14A-14D depict a customized, single piece, micro oral PAP devicemanufactured by “Bite only” micro-cellular foaming injection molding;

FIG. 15 depicts a single step manufacturing method for hollow device byinjecting material in two cavities, cavities rotation, followed byinjecting plastic at intersection of two halves, creating hollow part;

FIG. 16 depicts micro-holes in the hollow tube (or hollow passage way),blowing air at very low flow rate, but stimulating the tongue to stayforward original position (does not allow to fall back) during sleep.These micro-holes can be near the tongue (lingual area) and/or at theend of throat area (oropharynx area); and

FIG. 17 depicts special microchip embedded into mouthguard for nervestimulation hand a plurality of metal stimulators. It's designed to bein close proximity to the nerves of the tongue muscle. This reduces thetongue falling back during sleep, allowing more open airway passage.

DETAILED DESCRIPTION

The teachings relates to device designs, working function of device, andmanufacturing methods for single piece, micro, tubeless, cordless,anti-snoring (AS)/sleep apnea treatment (SA) devices where airflow fromthe front of the mouth is directed from the device to the back of themouth, bypassing the soft tissues, palates, tongue etc., directly to theoropharynx or laryngopharynx area, with or without use of micro-blowers.If micro-blowers are not used, the device can have micro-sensors andmicroprocessors attached to front hollow housing. The sensors can beinsert molded in the inner piece of the device. The device can beattached to the upper arch (teeth) or the lower arch (teeth) or to botharches. The design of the device allows for simultaneous nose breathing.The device can be Non-customized or customized for the individual.Air-flow is directed to the oropharynx area (throat area) from the mouthopening (lips area) using a front hollow housing and hollow tubes (ordifferent hollow passage ways designs) bypassing soft tissues. In caseof an Auto PAP device, the desired pressure and airflow is achieved(automatically adjusted continuously during sleep) using micro fan(s),sensors and microprocessor having closed loop feedback control systemand proprietary algorithm using a compact control module inserted insidethe front hollow housing of the oral or oral/nasal device. Sensors withlow energy battery can also be attached to mouthguard during injectionmolding process for compliance and few data acquisition purposes. Thedevice has the capability to record data within the system using amicro-SD card or to transfer data wirelessly using Bluetooth or cloud topermit live monitoring of the medical condition of the individual andtreatment compliance.

In addition to an auto continuous positive air pressure (Auto CPAP) ornon-auto continuous positive air pressure (conventional CPAP) controlledmechanism, the oral device can also bring lower jaw forward (mandibularadvancement device—MAD) reducing further occurrence of the sleep apneaand snoring significantly, referred to herein as: A. PAP-MAD withoutmicro-blower but with micro sensors and microprocessor or B. CPAP-MADwith micro-blower(s) more micro-sensors and microprocessor or C.Auto-CPAP/MAD with micro-blower(s) having sensors and closed loopcontrol system and proprietary algorithm to have comfortable(auto-adjustable) pressure/air flow during sleep

The device can also be modified to use as a diagnostic sleep apneadevice with additional sensors. The device can be controlled wirelesslyto set parameters such as pressure, flow rate etc., by any wired orwireless device such as a smart phone, smart notebook etc., usingBluetooth type or other wireless technologies.

The teachings relates to oral or nasal or a combination of oral andnasal device for treatment and diagnosis of obstructive sleep apnea andsnoring; having microprocessors and sensors, comprising of followingconfigurations and all devices are with or without mandibularadvancement (MAD):

-   -   1. Oral Device having micro-blowers and control module—positive        airflow (PAP) device    -   2. Oral Device having micro-blowers and control module—auto        control positive airflow (APAP) device and proprietary algorithm        for auto adjustment of pressure and/or flow rate    -   3. Oral/Nasal Device having micro-blowers with positive airflow        (PAP or APAP) utilizing nasal passage for air delivery    -   4. Oral Device without micro blower and with or without        microprocessor, sensors and data acquisition system    -   5. Above oral devices with capability for testing sleep apnea        known as HST or OOCST (out of center sleep testing) diagnostic        PAP device and capability to treat OSA

All above configurations without mandibular advancement (MAD) can beprovided with upper mouth piece only (i.e. without the lower mouthpiece) or with lower mouth piece only (i.e. without the upper mouthpiece). The Non-customized device or customized devices (to fitindividual's teeth) are supplied in different sizes such as small,medium and large. Both non-customized and customized devices consist oftwo pieces A and B as shown below: A. front hollow housing (in whichmicro fan(s), sensors, microprocessors etc. are inserted aftermanufacturing) and B. inner mouth piece with hollow air passage way.

Front housing has snap/un-snap fit concept where front hollow housingsection is easily snap-fitted with inner mouth piece and also can beeasily un-snapped (removed from inner mouth piece). Below aremanufacturing methods: A. Front hollow housing with is made by injectionmolding. To prevent air leakage between hollow housing and inner mouthpiece, an elastomeric ring is mounted on front housing or elastomericring is molded in one step process as two shot injection molding. B. Forinner mouthpiece, the following manufacturing methods are used toachieve predetermined hollow passage ways. The inner mouth piece isdivided into two portion: 1. Partial hollow tube and 2. Mouthguard(upper or lower arch) 1. Multi-step process: 1. Separately injectionmold partial hollow tube and mouthguard (or two shot molding ofmouthguard where it can be soft/hard material or “boil bite” softmaterial with hard material) followed by bonding of partial hollow tubeand mouthguard to create hollow passage way in inner mouth piece. Thebonding can be mechanical, vibration welding, laser welding oradhesively bonding; 2. One step injection molding process where partialwalls of tube and mouthguard are molded in two cavities of a singlemold, followed by rotating cavities where two halves are aligned andsecond material is injected at intersection, bonding these two piecesand creating hollow structure. Here, the second material is softmaterial or “Boil and Bite” material, creating customized oral device ina single step process; 3. Water or gas injection molding to achievehollow air passage way; and 4. Lost core foam injection molding

Both non-customized and customized devices are manufactured to fit theindividual's teeth (upper arch, lower arch or both). The customizeddevice provides better fit and more comfort. The customized device isalso supplied in 3 different sizes such as small, medium and large basedon internal teeth arch sizes of different individuals.

There are different manufacturing methods for customized devices suchas: 3D Printing of Device—This is accomplished by scanning of the teethor creating an impression of teeth, creating a CAD file of teeth for 3Dprinting of the device, followed by 3D printing of hard or hard/softdevice in a single step. Here, hollow sections such as tubes and hollowhousings are manufactured in a single step, due to design freedom of 3Dprinting process. “Boil and Bite” concepts such as: a) Over-molding of“Boil and Bite” material on 3D printed part (also known as insertmolding): This is accomplished by injection molding of soft “Boil andBite” on hard 3D printed hollow device (part) as an “insert” ininjection molding tool. b) Over-Molding of “Boil and Bite” material onpreviously hollow Injection molded device (part): Injection molding ofsoft “Boil and Bite” material on previously injection molded hollowdevice as “an Inert” (here, hollow structure for housing andtubes/hollow air passage way can be manufactured by several methodsdescribed above. c) micro-cellular foaming injection molding processwhere micro-cellular foam material is injected on top of mouthguard.

The device can be single piece construction, if the device does notcontain any sensors/microprocessor or sensors/microprocessor and batteryare completely sealed, then no need to have snap-fit feature. Thissingle piece construction can be achieved by bonding of two separateinjection molded halves at pre-determined line (or separately injectionmolding hosing with partial tube and mouthguard) followed by bondingthese two pieces to create hollow structure or by water injectionmolding or by lost core foam injection molding.

In all cases, it is recommended to replace mouth piece from fronthousing or replace “boil and bite” portion of mouth piece once it wearsout in order to protect the teeth, keeping correct teeth alignment andnot creating TMJ. The front hollow housing with or withoutmicroprocessor and sensors can be reused.

For both Non-customized and customized devices, they can be used withoutmicro-blower where air flow is directed from the front to oropharynxarea due to hollow tubes or hollow passage ways. Here, the device canhave microprocessor and key sensors to provide feedback on sleep qualityand AHI index as well as compliance.

For both Non-customized and customized devices a micro-blower ormultiple micro-blowers can be inserted into the front hollow housing ofthe device. The micro-blower continuously blows air into hollow internalairflow passages attached to the mouth guard, thus working as aconventional CPAP machine, but without any external tubes or wires orcords attached.

For device described above, the device can also be fitted with a controlmodule having microprocessor and sensors for pressure, airflow rate,temperature, pulse rate and oxygen saturation, snoring pattern, positionduring sleep, respiratory efforts etc. with a closed loop control system(hardware). This embodiment allows for the automatic control of airflowpressure and/or air volumetric flow rate as in Auto CPAP or Bi-CPAP typemachines without the need for external tube, wires, cords, fittingsusing proprietary algorithms built into the device unit command module.

The device brings airflow from the front of the mouth to back of thethroat (pharynx area) and can be combined with mandibular advancement(bringing the lower jaw forward) to further assist in mitigating snoringand sleep apnea, referred to herein as PAP-MAD without micro-blower orCPAP-MAD with micro-blower or Auto-CPAP/MAD with closed loop controlsystem.

The device may comprise the capability to record data by micro-SD cardor wirelessly transfer data for real time monitoring and treatmentcompliance. The device can be controlled wirelessly using mobiledevices.

One embodiment of the teachings comprises tongue depression design ofhollow tube (or any hollow passage design). This serves two purpose:bring the air from outside to back of throat and same time keeping thetongue down, keeping more air passage open at the oropharynx area.

One embodiment of the device comprises of utilizing PVDF sensortechnology with airflow and apnea/hypopnea detection already calibratedoff the shelf strips (from Dymedix) or standard PVDF film strips thatcan be mounted in our device with proprietary algorithm to enableCPAP/APAP type operation for all the above PAP devices identified above.

One embodiment provides special design at back of the upper or lowerarch of mouthguard which attracts the tongue to stay forward positionduring, keeping more air passage way open. One embodiment provides curvevertical semi-rigid plastics strip (fish tail shape) attached to hollowside tubes on both side, which pushes upper lip mouth area outward,keeping nasal air way passage open, helping further air coming from noseduring sleep, reducing snoring and sleep apnea.

One embodiment of the teachings comprises providing micro-holes in thehollow tube (or hollow passage way), blowing air at very low flow rate,but stimulating the tongue to stay forward original position (does notallow to fall back) during sleep. These micro-holes can be near thetongue (lingual area) and/or at the end of throat area in a hollow tube(left and right) connecting the end of the two sides of hollow tubes ofupper or lower each, directly blowing air to tongue and to soft palatesof throat region. Slight disturbance of tongue and soft palate by airfrom these holes may be sufficient, not allowing soft tissues to relax,keeping air passage way open during breathing during sleep withoutwaking up an individual.

Other embodiments envisage using nasal or oral-nasal delivery of airflow from device with or without auto control module and micro-blowers.One embodiment of the teachings comprises that the light source andpulse oximeter probe can be mounted outside the lip on vertical plasticstrip which is part of hollow housing while the light detector ismounted on the mouthguard. Other concept of wired pulse oximeter can bemounted on ear lobe. Wireless pulse oximeter can be mounted on finger orany other location as done by conventional pulse oximeter. Theinformation can be transferred to Bluetooth of the teachings device orBluetooth of the smart phone or any such device.

One of the benefit of the device compared to current PAP machine is thatthere is no need to vent the air during exhalation since device allowsto exhale thro' nose even when the micro blower is continuously blowingair during exhalation.

One embodiment of the teachings comprises special microchip embeddedinto mouthguard for nerve stimulation. The ultra-small neurostimulator,is mounted on the mouthguard (bonded to mouthguard or insert molded thistiny chip in plastic during injection molding of mouthguard). It'sdesigned to be in close proximity to the nerves of the tongue muscle forstimulation. This reduces the tongue falling back during sleep, allowingmore open airway passage.

Other embodiments envisage using nasal or oral-nasal delivery of airflow from device with or without auto control module andmicro-blower(s). One embodiment of the teachings comprises an impactsport guard with additional airflow during the sports activity andprotection of teeth. This embodiment is referred to herein as a positiveairway pressure impact sports guard with or without micro-blower(s).This is accomplished by front housing having impact absorbing materialor a 3-D printed lattice structure to absorb and distribute energy awayfrom the teeth.

One embodiment of the teachings comprises that the light source andpulse oximeter probe can be mounted outside the lip on plastic which ispart of hollow housing while the light detector is mounted on themouthguard. Other concept of wired pulse oximeter can be mounted on earlobe. Wireless pulse oximeter can be mounted on finger or any otherlocation as done by conventional pulse oximeter. The information can betransferred to Bluetooth of the teachings device or Bluetooth of thesmart phone or any such device.

The device can also be configured as a sleep apnea diagnostic device todetect OSA. For this use, the device has various sensors located in thehollow housing and/or the maxillary or mandibular arches which would becapable of measuring and recording oxygen saturation in blood and pulserate (pulse oximeter), air flow rate, respiratory effort byBluetooth/wifi enabled effort belts (RIP belts); temperature, position(tilt), Single lead ECG sensor packages with wireless connectivity canbe used to monitor and record heart rhythm; also EEG sensors packagescan be incorporated to monitor and record brain activity. Also insidemouth camera can be used to monitor changes in air passage. Proprietaryalgorithms can be applied to this data to determine AHI which could becorrelated to standard Sleep diagnostic tests such as PSG or PG.

The device can be modified to serve as a sleep apnea diagnostic device.For this use, the device has more sensors located in the front outsidehousing and/or maxillary or mandibular arches such as differentialpressure to measure air flow; pulse sensor to measure oxygen saturationin blood, pulse rate, temperature; a position sensor (tilt sensor) toindicate position of body while at sleep, Sound sensor to measurebreathing variation and snoring; miniature video camera on themouthguard to take pictures of inside of mouth during sleep; PVDF basedsensor for air flow and temperature measurement; respiratory effortsensor (RIP belt). These data along with heart rate can provideinformation on AHI (Apnea Hypopnea Index) number for the individual(level of sleep apnea) as well as ability to discriminate between OSAand central apneas. EKG probes can be used for monitoring heart rhythmwhich can communicate with the device with wireless technology. Alsoadditionally EEG sensors can be incorporated to measure brain activityand provide data on actual sleep time. The device can perform asdiagnostic tool (as Home Sleep Testing (HST) or Out of center SleepTesting (OOCST) for detecting OSA.

The device can also be used to titrate oral appliances such asmandibular advancement (MAD devices) and help select appropriatetreatment without extensive sleep lab or home sleep testing. HST can beconducted with different mandibular advancement positions and theDiagnostic results from each overnight sleep study (HST) with differentpositions compared to select the best position for optimal treatment.

The device can also be configured with PVDF sensors applied to thepatients' area above the lips and below the nostrils with a Dymedixsensor (previously calibrated) or with a PVDF film installed in thehollow housing and/or the maxillary or mandibular arches, with airflowand apnea/hypopnea detection capability to provide HST capability. PVDFfilm has a property that allows it to produce an electrical signal whenvariation in force, sound, acceleration, pressure, or heat is appliedsuch as by airflow with varying temperatures (breathing in andexhaling), snoring sound, moving while asleep, etc. This signal can becaptured and magnified by proper filters and amplifiers to producewaveforms as utilized by PSG/HST diagnostic devices and can be monitoredand stored to provide and record indications of snoring, apnea/hypopneaand so on. The PVDF sensor would replace or enhance the sensors alreadyindicated above.

In one embodiment the device can deliver compounds and or excite orstimulate appropriate nerves in the mouth to open air way passages.According to the present teachings, each device within the specificationcan be used with or without microblowers. Turning to the figures, FIG.1A depicts an individual with no sleep apnea treatment device insertedin the mouth. Oropharynx area (upper airway) 15 is almost closed duringsleep causing sleep apnea or snoring. In FIG. 1B, the same individualshown in FIG. 1A is depicted having a sleep apnea treatment device 13according to the teachings inserted into the mouth, and oropharynx area15 (airway passage) is less obstructed as air comes from the front ofhollow housing of device and is delivered to the oropharynx area,completely bypassing air flow restriction areas such as soft palates,and tongue during sleep, reducing sleep apnea or snoring. Directcontinuous air delivery during inhalation reduces sleep apnea occurrenceas the airway passage is less obstructed.

FIG. 1C depicts a CAD drawing for the device 13. FIGS. 1D and 1E showsdifferent designs of device. All FIGS. 1C,1D and FIG. 1E having an upperarch can be customized using several mentioned methods. FIGS. 1D and 1Ehave sensors and/or microprocessor 127 mounted in the outer housing nextto hollow airway passage opening. This sensor helps doctor to determinethe patient compliance, sleep information and other parameters real timeand/or over long period of time. FIG. 1C depicts a front top perspectiveview and FIG. 1E depicts a rear perspective view of one embodiment ofthe device of the teachings. As shown in FIG. 1C and FIG. 1E, device 13comprises three main components: hollow front housing 110 with frontopening 126 for air entrance and 127 space for microprocessor andsensors (for FIGS. 1D and 1E), hollow side tubes 115 which bring airfrom hollow opening 126 in hollow front housing 110 to oropharynx area15 as seen in FIG. 1B and upper arch 100 which can be Non-customized orcustomized. Upper arch 100 can be made of single material or cancomprise soft material 121 touching the teeth and semi-rigid material122 on outside, facing lower teeth as shown in FIG. 1F. FIG. 1G showsthe device 13 with strips to keep tongue down. FIG. H showsmicro-processor and sensors attached to front housing.

Hollow side tubes 115 can be manufactured using the same materials asrest of device 13 or they can be manufactured from material 122 that isslightly more rigid than upper arch 100 material 121 as shown in FIG. 1Fso they do not collapse, restricting the airflow. The rigidity ofmaterial also allows withstanding teeth grinding forces during sleep. Byusing a high modulus material, the wall thickness of hollow side tubes115 and hollow front housing 110 can be in the range of 0.3 mm to 2 mm,the overall size of device 13 can be reduced, making device 13 morecomfortable and increasing internal hollow space for airflow. Hollowside tubes 115 can be coated in their interior surfaces to reducefriction. Hollow side tubes 115 can be made of plastic material havinglow coefficient of friction, to minimize the air pressure drop fromfront air entrance area to exit at the back of throat area. Anotherprimary cause of reduced air flow is turbulence, caused by the flow ofthe air when traveling in an indirect pathway. Where the air flowtransitions, there should be a smooth transition curve which will resultin less turbulence (smooth transition), so airflow will not be effected(laminar flow rather than turbulent flow). This will reduce the incomingair pressure drop, requiring less pressure need. Less air turbulencewill also reduce air flow noise.

Hollow side tubes 115 can also have outer surfaces made of soft materialfor the comfort of the individual. The inside diameter (cross-sectionbased on design) of hollow side tubes 115 can be constant or the insidediameter can be reduced slowly from front hollow housing connectiontowards the oropharynx/throat area to increase the air velocity, furtheraiding reduction of obstruction in the upper air passage. This alsohelps in increase response time when an Auto CPAP concept is used. Ascross-sectional area decreases, air velocity increases inside hollowside tubes 115. The law of conservation of mass means that the size ofhollow side tube 115 can be calculated to provide a desired air velocityusing the following equation:V ₂=(V ₁ *A ₁)/A ₂

-   -   V is velocity and A is Area

Device 13 can be designed (figure not shown) to be used with a lowerarch (lower teeth) only rather than an upper arch 100 as shown in FIGS.1C and 1E. In this embodiment, the front hollow housing 110 (for airflow) and hollow side tubes 115 are attached to the lower arch of themouth guard, eliminating the need for the upper arch mouth guard.

FIG. 1J shows few cross sections of device from front of the housing tooropharynx area (towards throat area) as per FIG. 1I. The cross sectionof hollow tubes or hollow air passage ways is determined by AHI index ofan individual and required air flow rate and pressure.

FIG. 1K shows different designs of hollow tubes and hollow passage ways.The hollow passage ways can be in the form of tubes—round, oval,rectangular or any other size and dimension based on required airflowand pressure determined by hand calculation or by computational fluiddynamics (CFD). The hollow passage ways can be buccal side, lingual sideor at occlusal area (between the upper and lower teeth). The hollowpassage ways can be reduced in dimension from front to back. The lengthof hollow air passage way can be varied.

The hollow passage way can have micro holes at predetermined area fromfront to back just to excite tongue to stop it falling back, keeping airpassage way open. The hollow passage way from two side tubes can beconnected at the throat area having other hollow tube, creating “C”hollow section and there are holes only in tube at throat area toprovide controlled air flow and pressure to reduce sleep apnea. FIG. 1L,FIG. 1M and FIG. 1N depict cross sections of one embodiment of a sleepapnea treatment or anti-snoring device 14 without micro-blowers havingboth upper and lower arches 100, 101 where hollow side tubes 115 areconnected with upper arch 100. FIG. 1L and FIG. 1N depict a CAD drawingwhile FIG. 1M depicts the CAD drawing of an alternative design havingmicro holes which apply air to the tongue or soft pallet or throat area.Upper arch (maxillary) 100 and lower arch (mandibular) 101 of the device14 have dimensions fitting upper and lower teeth of the wearer such thatthe device 14 does not move the lower jaw forward as would a MAD(mandibular advancement device).

Buttons or any snap fit design or matching tabs design on arches can beused to keep upper arch 100 and lower arch 101 of the device 14 togetherduring sleep. Hollow front housing 110 comprises an opening 126 in thefront of the device 14 where air enters and exits during breathing(inspiration and expiration). Hollow front housing 110 can be of anyshape (rectangular, oval, square, round etc.) and is not limited to theshape depicted in FIGS. 1B to 1L. The size of hollow front housing 110depends on the person's mouth opening size. For Non-customized devices,the size of hollow front housing 110 is designed in such a way that itwill cover majority of the population having different facialdimensions, and can be manufactured in small, medium and large sizes.For customized devices, the device substantially fits the individual'steeth, but it is not necessary to cover all teeth as long as device doesnot come out during sleep.

FIG. 1O-1R show the sections of the device (fitting upper and lowerarches/teeth) with front hollow housing opening having micro-sensors andmicroprocessor. FIG. 1N depicts an individual with full sleep apneadevice while 1P depicts the device with a front portion removed, thusallowing for disinfection of only the moth portion, unsnapping the fronthollow housing after the use of device.

The non-customized or customized device can be a single piececonstruction made out of semi-solid material, elastomeric material orhard/soft (soft in contact with teeth) materials. The device can be madeby injection molding or/and two shot over-injection molding or insertinjection molding processes or thermoforming processes, followed bybonding technologies as described earlier. Single piece design or twopiece snap fit design with tubes (hollow air passage way), compactconstruction, fit, finish and comfort are the key factors used in thedesign, selection of materials and manufacture of the device.

FIG. 1Q depict air entrance opening 126 in hollow front housing 110 andair exit opening 130 from upper arch hollow side tubes 115 duringinspiration. FIG. 1R depicts a cross section of device 14. FIG. 1Qdepicts device 14 with hollow front housing 110 and hollow side tubes115 attached to upper arch 100. Hollow front housing 110 can becompletely detached and easily attachable at intersection 135, snap fitconnection. FIGS. 1S-1Y represent various views of the device shown in1O.

Further the top of housing part 110 can be split into 2 snap fitcomponents if needed, permitting easy assembly and access for theelectronics including micro-blower that will be mounted inside thehollow front housing 110.

The snap fit design (connect and disconnect of hollow housing from innermouth piece) is essential to clean the device after every night and alsoto replace the inner mouthguard after few months as it wears out due toteeth grinding forces. Patient has to order only inner mouth piece andconnect with original front housing to function like new device,reducing cost. For the customized “Boil and Bite” soft portion can bechanged after certain usage if “boil and bite” is mechanical attached torigid arch, further reducing the cost to patient and also frequentchange reduces the bruxism or jaw deformation.

FIGS. 2A-2C depict one embodiment of a device 24 having air entranceopening 226 comprising a curved hollow air tube 230 connected fromhollow front housing 210 directly to the center of upper arch 200,bringing air directly from the outside of the mouth to the back of themouth. FIG. 2A, FIG. 2B and FIG. 2C and FIG. 2D and FIG. 2E are CADdrawings showing different views of the device 24. In this embodiment,the mouth has to be kept open slightly to permit the hollow air tube 230to pass the teeth area and this is accomplished by putting tabs orspacer on bottom of upper arch and top of bottom arch or using the tube230 to create this separation to allow pass-through. Here, spacerbetween upper and lower arch is built in (molded) to allow the centerhollow tube pass through when device is inserted in the mouth, withouttouching the teeth. FIG. 2C depicts hollow tube without spacer can beused to separate upper and lower arch to direct the air flow from frontof mouth to throat area. It works as spacer as well as hollow airpassage way.

Curved hollow air tube 230 can be curved slightly downward so that itcan apply pressure downward on the tongue such that the tongue does notfall backward during sleep, helping to keep the upper air way passageopen (oropharynx area of mouth) and reducing the sleep apnea. Furtherthe tube 230 will be flexible in the lateral domain to permit smallsideways movement of the tongue for comfort. Curved hollow air tube 230can be of any shape, round, square, rectangular. Curved hollow air tube230 can be made of single material or multi-material where outsidematerial is softer than internal material for individual's comfort. Thisconcept can be used with or without mandibular advancement and with orwithout CPAP or Auto-CPAP having micro blower(s). The center hollow airpassage way can be hollow spoon shape so that it can apply pressure ondownward on the tongue, larger surface area than just the abovementioned hollow tube, further preventing the tongue to fall backward,helping even more air way passage open, and further reducing sleepapnea.

In one embodiment, curved hollow air tube 230 can be used along withhollow side tubes 215. FIGS. 3A and 3B depict one embodiment of device34 to keep the tongue forward (not allowing the tongue fall back). Ifthe device 34 is made to fit only the upper arch teeth or lower archteeth, then multiple strips 340 can be joined accordingly as shown fromleft to right of the mouth guard arches 300, 301 (not shown in figure).Strips 340 can be straight, concave or convex. Strips 340 can be made ofpolymeric elastomer material. To stop the tongue from falling back, twosided pressure sensitive or moisture sensitive or any other chemistrytype adhesive tape 350 in the form of small buttons or other shapes likerectangular tape can be used to cover the strip in whole or in part.Before placing the sleep apnea device 34 in the mouth, the adhesivebuttons or tape 350 can be placed on one or more strips 340 by removingrelease paper on one side of the adhesive tape or buttons 350. Then, theother side of the adhesive buttons or tape 350 is exposed by removingrelease paper and the device 34 is inserted in the mouth. The adhesiveof the adhesive buttons or tape 350 bonds to the tongue. The elasticityof adhesive and design of the adhesive buttons or tape 350 will allowsome movement of the tongue from left to right or right to left, butwill keep the tongue in a forward position, stopping the tongue fromfalling backward and keeping the airway passage open. Directionalelasticity of the adhesive can allow significantly more movement oftongue from left to right or right to left compared to inward movementtowards throat, not falling back. This will increase comfort levelduring sleep as some movement of tongue is allowed. It is also possibleto hold the tongue in a forward position by putting the adhesive buttonsor tape 350 at the back wall 315 of hollow front housing 310/arch 300,301.

FIGS. 4A-4E depict a device 44 having micro-blower(s) 445 withcontinuous positive airflow (oral CPAP device) concept without automaticfeedback control of pressure, flow rate, temperature, but with built-inmicroprocessor and sensors in device for compliance and monitoringpurpose. FIG. 4A depicts a cross section of device 44 having Nanofan(s)or micro blower(s) 445 with sensors/microprocessors etc. 455 is thedirection of flow in the interior 414 of hollow front housing 410. Here,micro blower(s) is attached horizontally to front housing, bringing theair flow from bottom of the hollow housing. While FIGS. 4B and 4C showsdevice where micro-blower(s) is mounted vertically, bringing the airflowdirectly from front housing to hollow tubes or hollow air passage way.This is most preferable way of mounting the micro blower(s) since thisattachment provides less resistance to air flow and less flowturbulence. This design also provides ease of device manufacturing. But,in few types of micro-blowers, vertical mount may not be feasible.Sensors, microprocessors, USB drive, batteries etc. are inserted in openchamber 460 of the front housing next to micro blower opening in FIGS.4B and 4C. Device 44 is depicted in FIGS. 4A, 4B and 4C having microblower(s) 445 in the interior 414 of hollow front housing 410 havingsensors, microprocessor, batteries and USB card, Blue tooth port etc.The mounting of these sensors and other items are discussed in FIG. 7.The dimensions of the walls of the hollow front housing 410 depend onthe type of material and manufacturing process. The dimensions ofopening 426 of hollow front housing 410 vary depending on the type andnumber of micro blowers 445 that are used. When micro-blowers 445 areinserted when opening 426 is in the front of hollow front housing 410,micro-blowers 445 have a tight fit with the inner wall of hollow fronthousing 410. Elastomeric/rubber gasket can be used to prevent orminimize air leakage. As shown in FIG. 4A, micro-blowers 445 rest onbottom walls on both sides of hollow front housing 410 having bottomopening 455 for air entrance. Gasket material can be used to seal thefront opening 426 of the hollow front housing 410 around the wall ofmicro-blower 445.

The front or bottom opening 455 of hollow front housing 410 allows forair flow for micro-blowers 445. This way, during inhalation, asmicro-blowers 445 turn on, air comes in from the bottom opening 455 ofhollow front housing 410, exits hollow front opening 410, moves otherside of micro-blower(s) and then moves into hollow side tubes 415,directing air directly at the oropharynx area. It is possible toincrease the pressure or velocity of incoming air by reducing the sizeof the hollow side tubes 415 from the entrance at the hollow fronthousing 410 to the exit in the oropharynx area. It is also possible tochange the pressure and flow rate of incoming air by changing thevoltage supply to the micro-blower(s). The arrows in FIGS. 4A, 4B, 4C,4D and 4E show the airflow directions from opening of the hollow fronthousing 410 through micro blowers 445 to the hollow side tubes 415 tooropharynx area (throat area) and can have a 3 to 5 times the tidalvolume. Only difference is that micro-blower(s) are mounted vertically,directing the air flow straight into the hollow tubes or hollow passageway in case of FIG. 4B and FIG. 4C. FIG. 4B shows embodiment withmicro-blower mounted vertically and allowing for straight air flow toback of mouth. FIG. 4D depicts a person wearing this kind of oral CPAPdevice.

The design of device 13 envisages placement of the micro-blower atcenter FIG. 4A and FIG. 4C or on the side of front hollow housing asshown in FIG. 4B When the blower is placed on the side as opposed to thecenter, the dimensions on both tubes or either hollow passage on deviceinside the mouth will be adjusted to get even flow rates from bothhollow passage discharges of air at back of mouth (oropharynx area).

This continuous positive airway pressure oral device (PAP or CPAP),provides unobstructed breathing by delivering a constant flow of airthrough the side tube(s) or center tube(s) or any other hollow airpassage designs connected to the front hollow housing, directly to upperair passage way. The oral device with housing is designed such a waythat when individual wears it, it is secured to the lips so that littleor no air escapes from the front. Also, the micro-blower(s) areconstantly running, so exhalation will mostly occur through nose. Due tothis constant level of airflow during inspiration, air pressure, airflow and air velocity increases in the oropharynx (throat area) so theupper airway does not collapse during inhalations while sleeping. Airflow from the micro-blower can be adjusted by control module asrequired.

Although this is not an Auto-CPAP type device but only a CPAP typedevice, the device can adjust the micro-blower output to matchinspiration and expiration cycles based on temperature sensors, ifneeded but constant running of micro-blower(s) is preferred.

A variety of suitable micro-blowers are shown in FIGS. 5A-5D. Dependingon the individual's requirement (based on sleep study), a specificmicro-blower type and size can be selected to have fixed volumetric airflow rate up to 30 liters per minute and/or air pressure of up to 30 cmH20 (3000 pascal). It is possible to change (set) the pressure andvolumetric flow rate of the same micro-blower manually. A CFD(computation flow analysis) will be used to determine and demonstratethe efficacy of the device under various design parameters andbiological physiologies.

Micro-blowers with different mechanisms can be used including but notlimited to the following: The micro-blowers can be based on conceptssuch as Piezo-nanofan 570 shown in FIG. 5A. The Piezo nanofan consistsof blades made of stainless steel, brass or even Mylar. Attached to theblades is a patch of piezoelectric ceramic material. Piezoelectricmaterial deforms in the presence of a voltage field. Positive andnegative electrical voltage affect the material differently. As apositive voltage is applied, the ceramic can expand, causing the bladeto move in one direction. A negative electrical voltage can cause theceramic material to contract and move the blade back in the oppositedirection. The fan's speed can be adjusted by changing the frequency ofthe current. The nanofan or micro blower can be based on axial air gaptechnology 571 as shown in FIG. 5B with almost no power loss. One canuse roots blower 572 as shown in FIG. 5C, a more positive displacementpump. One can use a micro-blower concept using-Air Multiplier 573 asshown in FIG. 5D (powerful airflow, no blade). The Air Multiplier is ablower with an unusual characteristic in that it does not have anyvisible blades. It appears to be a circular tube mounted on a pedestal.The shallow tube is only a few inches deep.

One can use centrifugal fans, of which there are 3 majorclasses—forwardly curved, backwardly curved or straight-bladed. Theygenerally move less air but at a higher pressure. Some fans are calledcompressors if they turn at sufficient speed to materially compress theair they are moving. Centrifugal fans are usually mounted in a housingthat looks like a snail shell. The inlet is in the center and thedischarge is the opening of the shell at the outer edge of the scroll.When the blower is integrated with a housing and a motor, it thenbecomes a blower.

One can use a plurality, such as hundreds, of Nano blowers instead ofmicro-blowers inserted into the hollow housing of the device. In case ofan SAT (sleep apnea treatment) or AS (Anti-snoring) device with severalnano-blowers, it is possible to generate the full range of treatmentpressures up to and in excess of a treatment number of 20 cm pf H₂O,because of the strength of the electrostatic force that drives thenano-blower plates, like bellows, open and closed, together and apart.Each nano-blower can push a small amount of air at significant pressure,and hundreds of nano-blowers work in parallel to achieve the requiredvolume to effectively treat the particular individual's sleep apnea. Dueto significantly less air leakage and pressure drop, the individual maynot need to have this high treatment number of pressure 20 to 30 cm ofH2O (current CPAP machine—30 cm of H2O or up to 3000 pascal), but can beachieved in case if it is needed. To reduce cost, these micro ornano-blowers can be manufactured by “roll to roll” (R2R) or similar lowcost, high volume manufacturing processes. Since, oral CPAP innovationdirects air directly from front of the housing to oropharynx area,bypassing the tongue and soft pallets, the pressure required issignificantly low compared to current CPAP devices. CFD data shows that2 cm of H2O can be sufficient, not 20 to 30 cm of H2O required fortraditional current CPAP machines. This is a great advantage since itwill significantly reduce the numbers of Nano blowers compared to nosemounted CPAP device, or less powerful or less number of othermicro-blowers described above.

The dimension (sizes and shapes) of the hollow front housing of thedevice depends on the type and size of micro-blower(s) and also for aspecific individual and face size or there can be three sizes offered(small, medium and large).—For example, a micro-blower is shown havingdimension of 17 mm×17 mm×8 mm fan, having volumetric airflow of 30liters per min (500 ml per second). Tidal volume (air volume displacedduring inspiration or expiration) without extra effort is 500 ml duringinspiration (for breathing). A typical respiratory rate for an adult atrest is 12 to 20 breath per minute, meaning each breath (in and out) is3 to 5 seconds. For example, given 2.5 seconds inspiration time(breath), tidal volume is 500 ml. For inspiration time of 2.5 seconds,air volume taken in is 500 ml (200 ml per second).

If this micro-blower is used (having capacity of 1 CFM=30 liter permin=500 ml per sec), air volume can be 1250 ml (500 ml×2.5 sec) perinhalation, increasing the airflow rate by 2.5 times then required innormal case. For patient suffering for sleep apnea, this will open theair passage in the oral cavity significantly and prevent the collapse ofsoft tissues in oropharynx and larynx, preventing mild to moderate sleepapnea and snoring. By using hollow tubes taking air directly to pharynxarea, air is brought in faster where needed, even further reducing sleepapnea and snoring event of patient. If one micro-blower does not performas needed, more than one micro-blower in series can be used to get moreairflow and pressure.

FIGS. 6A and 6B depict an Auto CPAP (APAP—Automatic positive airpressure) device 64 with Miniature Auto Control Module 605 inserted inhollow front housing 610 along with micro-blower(s) 645 and sensors 646.605 can be mounted horizontally or vertically depending on the type ofmicro-blower(s) used. FIG. 6C depict micro-blower(s) 645 and automotivecontrol module are mounted vertically in front housing. Control module605 is data-capable and records all information on events andcompliance. Control module 605 having a microprocessor with severalsensors 646 and micro-blower(s) 645 is placed directly in hollow fronthousing 610 of a single piece and may provide variable flow depending onthe response measures and calculated by the controller. Micro, oraldevice 64 having very small space in comparison to current Auto CPAPdevices where the control module 605 along with blower/motor 645 islocated remotely from the individual and airflow is brought through ahose or tube to the nose or mouth or both. Vertical mount of microblower may allow to reduce overall size of the device.

The microprocessor or micro-chip in control module 605 is incommunication with airflow (differential pressure), temperature, tilt,sound sensors and pulse oximeter 646 to provide continuous feedback ofchanges in any parameters to microprocessor. Sensors 646 not only can beattached to control module 605 but also to the mouth guard (inside arch600), further increasing the capability of device 64 for sleep apnea andalso other purposes such as diagnostic device as well as complianceinformation. Based on the history and AHI index, the microprocessorautomatically adjusts air flow rate/pressure to improve the comfortlevel of the patient. To reduce further discomfort and also keep airpassage way open for longer time, micro blower(s) may not be supplyingair flow continuously. This is achieved by using a thermistor sensor in646 which monitors the individual's breathing and send an output thatreduces the flow of the device 64 internal blower when the individualstarts to exhale. The exhalation temperature is higher than inhalationtemperature. The resulting lowered resistance prevents the individualfrom feeling as though he is “fighting” against the machine whenbreathing, reducing discomfort. The control module can be mounted insidethe front hollow as shown in FIGS. 6A and 6B or also can be mounted onthe top portion or bottom or side portion of the housing. Also it can besplit into multiple PCB's with varying configuration. Pressure sensorscan be used monitor the pressure delivered to the individual in all typeof PAP machine types.

Analog Temperature Sensor (breathing timing sensor) is a small packagethermistor which can be used for a fast response. This sensor can beplaced in a location where it can be contacted with exhaled air. Analogtemperature sensors provide a signal to the microprocessor indicatingthe start of the exhalation and inhalation cycle. The exhalationtemperature is higher than room temperature, indicating start ofexhalation, giving feedback to microprocessor to control micro-blowers.Start of inhalation is sensed by temperature or/and air pressure sensor.

A customized or Non-customized oral Auto CPAP type (automatic positiveairway pressure) device continuously monitors the sensor parameters andutilizing proprietary algorithms automatically varies the air flow orpressure as per individuals need. APAP adjusts the air flow (pressure)to improve upper airway passage opening to a comfortable level, not toomuch pressure or airflow then required.

Through the use of firmware (proprietary algorithm) on the controlmodule, the device automatically controls the air pressure and airflowrate by continuously changing air micro-blower's speed using closed loopcontrol system. It is not necessary that individual has to have allteeth, so long as the device can be held in the individual's mouth by afew teeth. The device has a fast-response micro-blower(s), pressuretransducer and microprocessor. The device control module discernsstoppage or blockage of breathing from data being collected from thevarious sensors and will accordingly adjust the air flow (pressure) fromthe micro-blower to varying preset values as per the proprietaryalgorithm. As discussed in connection with devices withoutmicro-blowers, the Auto-CPAP device with micro-blower can be attached toupper arch or lower arch, or attached to both arches with or withoutmoving lower jaw forward (like a MAD device). There is also an airfilter (washable or disposable) that can be attached in front of themicro-blower to filter dirt. Hypoallergenic disposable filters are madeof non-woven acrylic and polypropylene fibers with a polypropylenecarrier. The combination of materials helps block very fine particles,and some filters claim to have anti-microbial agents. The hollow housingcan be made of plastics having anti-microbial agents (with or withoutcontrolled release).

The micro blower and microprocessors etc. can be powered by coin type orother types of micro-battery or rechargeable (electric or USB type) coincell or other types of micro-battery such as a polymeric micro-battery.Data storage and transfer can be achieved by a variety of technologies,thus eliminating need for any cord or wires. Two such technologiesinclude Bluetooth® and micro-SD card. The device may incorporateBluetooth® technology such that the device is continuously synced (orsynced whenever desired) with any other Bluetooth® enabled mobile devicesuch as smart cell phone, tablet, computer etc. The mobile device canthen up link through the Internet to send the data from the device to anInternet server. The device can then provide sleep apnea related data toa device having an appropriate app, which data can then be analyzed andstored on the device and/or can be communicated/shared with doctors orother medical professionals or other third parties via email or viacloud. Using a smart phone or similar devices, it is also possible tosend input to control module of the device to set up initial requiredair flow (pressure) etc. for individual as needed.

Micro-SD card: The micro-SD card can store all sleep apnea data duringsleep and can be downloaded to a device such as a smart phone orcomputer at a later time. Other configurations of the device can includeWi-Fi capable. Additionally, the control module may have the capabilityto manual control if needed and OLED to show the state of the system.The control module may use an algorithm that learns from individual'sbreathing pattern and reduces device pressure on exhalation(expiration). Sound output from the device will be between 12 to 18 dBAduring normal operation. By CPAP industry standards that are consideredto be exceptionally quiet. Auto-off function puts the display backlightto sleep Functions offered on current CPAP devices can also beincorporated into this oral CPAP device or on mobile app to a connectedmobile device with display for power status, pressure and ramp time. Italso gives audio visual feedback when programming ramp and pressuresettings.

FIG. 7A depicts the cross section of an Auto-CPAP (APAP) front hollowhousing with micro blower 760 and control module 735 consisting ofvarious elements inserted in the hollow front housing of a device thatis in communication with mobile devices 770 to download (sync) the data.Elements include but are not limited to: LCD and touch screen control700 and on/off switch 701 Bluetooth® sensor 705 and micro-SD card 710,pressure sensor 715, airflow sensor 720, temperature sensor 725, soundsensor 730, and tilt (position) sensor 732, microprocessor with firmware740, rechargeable battery with USB port 745, material or fabric withhigh water absorption capability during exhalation and desorption duringinhalation 755, micro-blowers 760 and air filter 765. The sensors may bepositioned differently than shown inside the mouth in the mouthguard oralternate locations as required. 770 depicts a mobile device incommunication with Bluetooth® or other wireless communication link 775mounted with a sleep apnea device comprising a control module. 785depicts the respiratory belt (RIP) belt. 780 depicts pulse oximeter thatwill also communicate with the control module via Bluetooth or otherwireless methods. A material 755 is incorporated after the microblowerto absorb moisture of exhalation.

FIG. 7B depicts a schematic of the control module of a device to treatsleep apnea and snoring. The device has proprietary firmware/algorithmto operate in different modes such as CPAP, Auto CPAP, Bi-CPAP etc.Method of operation of a single piece tubeless Auto CPAP oral device:The control module is programmed with firmware/algorithm to perform thefollowing operations as shown in FIG. 7B. The individual puts the oraldevice in his/her mouth, fitting it well, and then turns the on/offswitch 701. The device can also be turned on using a connected devicesuch as a smart phone 770 via Bluetooth® 705. The start of inhalationcan be detected by setting a pre-determined value for temperature sensor725 (less than body temperature) or air pressure sensor 715 (atmosphericpressure). Air enters when the micro-blower 760 starts duringinspiration via a signal given by the microprocessor 740, based on inputfrom temperature sensor 725 and/or pressure sensor 715. The air isfiltered by filter 765 before entering in the hollow front housing 610.A material 755 incorporated into the control module area 605 has highwater absorption capability from the surroundings. If needed, thismaterial 755 can be soaked in water and incorporated in the hollow fronthousing 610 before sleep to achieve a level of humidity.

This material 755 does not affect the air flow due to its location inthe hollow front housing 610, but at the same time it picks up moistureduring exhalation. Moisture is then released in air during inspiration,the amount of moisture depending on air flow rate and temperature. Thehumidity level does not alter the pressure level or change thetherapeutic value of CPAP device, it just improves the comfort. Due tothe relatively tight seal of the device at the lips, there is little orno leakage and the individual can also breathe through the nose. Also,since the micro blower(s) are continuously running, air is alwaysentering thro' mouth during inhalation and exhalation. As air alwaysenters thro' mouth via micro blower, person more likely to exhalethrough nose, thus there is no need for tight seal of oral device atmouth.

The RIP Belt 785 and Pulse Ox 780 will continuously send data aboutrespiratory effort and oxygen saturation as well as Pulse rate viawireless methods to the control module and which can then be recorded onthe storage device. Sensors read pressure and flow rate values and oncethey deviate from predetermined set values, they provide input to themicroprocessor 740 of the control module 605 which in turn changes themicro-blower 760 speed up or down (changing the power supply level). Thecontrol module 605 is operable to determine the occurrence of an apneafrom a reduction in respiratory airflow below a threshold, and if anapnea has occurred, to determine the duration of the apnea and to causethe flow generator (micro-blowers 760) to increase the treatmentpressure/flow rate by an amount which is an increasing function of theduration of the apnea, and a decreasing function of the treatmentpressure/flow rate immediately before the apnea.

The start of expiration can be detected by temperature sensor 725 or airflow sensor 720 or sound sensor 730. During expiration, the speed ofmicro-blower 760 can be reduced to decrease resistance to airflow duringexpiration, for increasing comfort. Data-recording devices such a microSD card can be used to record multiple variables from the sensorsdescribed in FIG. 7 or can be wirelessly uploaded to servers. This willhelp to determine optimum pressure, but the most common measurement isindividual's “Apnea/Hypopnea Index” or “AHI”, where the goal is to getAHI to 5.0 or lower.

The same Auto CPAP device can also be used as BiPAP/VPAP by changing thealgorithm of the firmware on the control module to have different modesof operation during sleep as described below. Bilevel-PAP (BilevelPositive Airway Pressure) provides two levels of pressure: IPAP(Inspiratory Positive Airway Pressure) and a lower EPAP (ExpiratoryPositive Airway Pressure). Bilevel or variable level machines(BiPAP/VPAP) blows air in two levels, one for inhalation (IPAP) and onefor exhalation (EPAP). This method is used in situations where markeddifficulty breathing is present.

These devices can be available a) either in a range of air flow/pressurevalues so that individual will be able to obtain the device with thetreatment number appropriate for him/her, much like contact lenses or b)device will be made adaptive so that they will self-adjust (like somecurrent high-end APAP machines) to provide the exact pressure foreffective treatment

FIGS. 8A-8B depict the same concepts for the devices as above in FIGS.6A-6D and 7A-7B but the single piece micro oral tubeless device 84 hascapability of bringing the lower jaw forward (mandibular advancement) inthe same manner as MAD devices 80 as seen in FIG. 8A currently in themarket by opening of the mouth upper airway passage area (oropharynxarea). As seen in FIG. 8A, current MAD devices 80 lack a hollow fronthousing, microblowers or hollow side tubes in the mouth guard upper andlower arches 800, 801. Oral MAD CPAP device 84 shown in FIG. 8B and FIG.8B consists of CPAP module 805 (same as 605 in FIG. 6A) incorporated inhollow front housing 810, with hollow side tubes 815 (same as 115 inFIG. 1D) to deliver air directly to oropharynx area and design mechanism880 as an example to bring the lower jaw forward.

The lower jaw, mandibular, can be moved forward by other mechanismsavailable in the market. The single piece micro oral MAD/CPAP devicedesign mechanism 880 allows the mandible to be advanced in increments of1 mm or less with a protrusive adjustment range of at least 5 mm. Inaddition, reversal of the advancement is possible. The protrusivesetting is verifiable. It maintains a stable retentive relationship tothe teeth, implants or edentulous ridge and retains the prescribedsetting during use. This concept of mandibular advancement (MAD) can beused for customized or Non-customized device and also for CPAP,Auto-CPAP, Bi-PAP devices etc., along with other features/conceptsdescribed for other embodiments of the teachings as described herein.The current MAD devices on market, essentially only bring the lower jawforward by methods such as Herbst, TAP, EMA (strap) etc.

These current devices do not have any capability of measuring anyparameters of air flow during sleep or providing any titration data orfunctioning as a CPAP or APAP. Teachings Device shown in 8B has all thecapabilities (including the electronic package of command module andsensors) of all embodiments described earlier plus the capability ofmandibular advancement using various methods as shown in FIG. 8Aincluding variations to those indicated above (Herbst, TAP and EMA) toachieve this.

This oral device can have electrical stimulation capability forproviding mild shocks to the soft palates and tongue. When theelectronic sensors detect blockage of air passage (by soft palatesrelaxing or when the tongue falls back and blocks the airway passage),the device can provide a mild electrical stimulation, and alleviate theblockage of airway passage from persisting further due to above events.

It has been proven that side sleeping position reduces the sleep apneaevents by more than 20%. When individual moves from side position tosubprime position, the tilt sensor records it and the built-inproprietary algorithm (software) sends a signal to thin plastic sheet(or a patch on face) attached to the device and touching to lip(s) tovibrate. This reminds individual to sleep on side. The individual slowlyadjusts to this and over few nights adjusts to sleep on side withoutwaking up. One of the appliance designs is very simple that it will bejust upper mouthguard with outside housing having tilt sensor to remindthe individual to sleep on side.

This device can be used as impact sport guard with additional airflowduring play and protection of teeth. It is referred to as a positiveairway pressure impact sports guard without micro-blower(s). Such impactsport guards have a hollow housing in the front with two hollow sidetubes attached to upper arch of the device. They can also be used forpeople in contact and non-contact sports acting as a protection mouthguard as well as a device to increase air intake, just like breathingdeeply without the thought and effort. The impact blow abruption anddissipation characteristics are achieved by making device using additivemanufacturing (3D printing) technologies with lattice structure.

FIG. 9 depicts a nasal/oral device 94 with CPAP/MAD or Auto CPAPDevice/MAD. This nasal/oral device 94 can also be used withoutmandibular advancement (without MAD). Internal hollow tubes inside themouth (on upper or arches) can be blocked or eliminated in the oraldevice (no air flow going through the mouth), but two hollow flexibleconduits 916 are connected to two nostrils from the top of the hollowfront housing 910 of oral device in which micro-blowers 945 areattached; or the airflow can be from both nose and mouth if the internalmouth tubes are left open. This can be achieved by nasal elastomerichousing 990 (Like nasal pillows used in CPAP machines) snug fitting thenose where conduit 916 are coming out from the oral PAP device 94. Theend of each of the two tubes 916 has an expandable elastomericattachment or nasal cannula 995 or nose pillows for each nostril, snugfitting inside the nostrils which holds the two tubes 916 and nosehousing 990 in place during sleep.

The nasal cannula can also be kept in place by using strip around theears. The oral device 94 has two functions: 1. the hollow front housing910 with micro-blower 945 delivers air flow to nose by itself or alongwith the airflow through the mouth during inspiration instead of insidemouth 2. The oral device 94 holds the nose housing 995 with controlmodule, micro-blowers 945 and sensors and tubes 916, the whole airdelivery system, in place as device is attached to teeth (upper or loweror both upper and lower aches). This oral device 94 can have a mechanismto bring lower jaw forward (MAD device), further opening the air passageway in mouth.

This device 94 allows reduction of sleep apnea by providing natural airflow through nose (natural breathing) in combination with lower jawmovement (nose CPAP or APAP with MAD Device). The elastomeric housing990 snug fitting the nose have micro holes allow and controls theairflow during the expiration. Airflow from the hollow front housing 910can also be controlled during the expiration by reducing the speed ofmicro-blowers 945 if expiration should be slowed down. Note for Nasalairflow the technique to increase humidity is described earlier in FIG.7 while inhaling will be used.

Micro-Nasal PAP device: In a specific embodiment of the device, it canbe attached directly to nose with microprocessors and sensors. Thisnasal micro PAP device has external housing, snug fitting with nose withtwo hollow tubes going into nostril. The external housing has microblowers or nano-blowers with similar concepts of control module withpressure and flow rate sensors as described previously for the oral PAPdevices (FIGS. 4A-4D or FIG. 6B). It is a stand-alone single unit likeoral device but attached to the nose instead of mouth. The device has noexternal tubes or cords.

A fabric or film with directional nano pores structure can be disposedin front of the oral or nasal device to slow expiration. The device canhave breathable anti-microbial fabric or film with directional nanopores structure with or without micro-blower SA or AS device. Thisfabric can be placed in front of the hollow box where air enters intothe mouth or nose during inhalation. This fabric can be adhesivelybonded, or can be permanent or preferably removed every day to wash orinsert same one or new one (every moth) before using device. As theindividual breathes in, the fabric or film's nano structure design opensthe pores, allowing the individual to breathe in normally. Then, as theindividual breathes out, expiration is slowed as the nano structurepores closes slightly to create a gentle pressure that naturally opensthe airway and relieves snoring or mild to moderate sleep apnea.

The data acquisition capability of the oral devices of the variousconfigurations described above (FIG. 7A and FIG. 7B allows it to be usedas a diagnostic device for sleep apnea for diagnosis of Sleep BreathingDisorder—specifically obstructive sleep apnea and allows to setparameters for current CPAP machines or device of current invention.This oral HST device can essentially function as a stand-alone HST (HomeSleep Testing) or OOCST (Out of Center Sleep Testing) device such asResmed's Apnea link or Itamar's Medibyte and so on. In the presentsystem, it can be used to set parameter of oral sleep apnea device ofcurrent teachings.

The device is a multi-channel screening tool, that can measure all orselected parameters such as airflow through mouth or nose, snoring,oxygen saturation, pulse, temperature, body position, respiratory effortduring sleep, EKG, EEG by various sensors that are built into the deviceor linked via wired or wireless technologies such as Bluetooth or Wi-Fi.

The acquired data from this device can be used to calculateapnea-hypopnea index (AHI) based on the sleep time recorded based onproprietary algorithm which can generate a comprehensive sleep studyreport with a custom app or software. This AHI determination with otherparameters recorded would permit prescribing/specifying appropriateCPAP/APAP/BiPAP treatment option (setting appropriate pressure (and/orair flow rate) for PAP or pressure range (and/or air flow rate) for APAPdevices as well as MAD (Mandibular Advancement Device) treatment option(setting the position of the lower jaw advancement). The device can alsohave a miniature/nano IR or thermal imaging video camera which can helpdetect changes in the airway passage during sleep.

In one embodiment of the device, it can be used to validate themandibular advancement device (MAD) setting used for treatment of OSAand snoring (OS/SA). In this version, the device would have all sensorsmentioned above or limited sensors and built in capability on thecontrol module to discriminate the efficacy of the MAD treatment andvalidate the lower jaw advancement setting selected. If used limitedsensors, it would have 3 indicators that would indicate if the efficacyof the MAD treatment made a positive difference (ie reduce the OSA/AHIor reduced snoring) or made no difference or made a negative differenceand made the symptoms worse. The indicator can be a color coded system(such as green/yellow/red) or light up different labelled lights todepict the 3 outcomes. The efficacy of MAD device can be also be shownas actual AHI index number.

The devices can be of any constructions/concepts as described previouslybut not limited to: 1. only upper arch or lower arch device or devicewith both arches 2. Both upper and lower teeth arch without bringinglower jaw forward 3. Both upper and lower teeth arch where lower arch isadjustable to bring lower jaw forward, 4. Center hollow tubes/hollowpassage ways or strips or any other design to keep tongue down.

The various embodiment of the device described above also work as nightguard to prevent bruxism, teeth grinding and also treat TMJ in additionto reduce snoring and sleep apnea.

FIG. 10 depicts thin plastic bag attached to upper arch of mouthguard(at the end, throat area) which expands and stays expanded during airflow from micro blower, stopping soft palates to collapse, allowing moreopen airway passage. If device has no micro blower, during normalbreathing this bag will expand during inhalation and collapse duringexhalation but stays in place due to specific bag design and supportdesign with upper arch. It is also possible to have dome same semi-rigidplastic bonded with upper arch which will not allow the soft palate torelax, keep in place during sleep.

The Non-customized device or customized devices (to fit individual'steeth) are supplied in different sizes such as small, medium and large.The device can be made by snap-fitting injection molded hollow fronthousing with rest of the part—hollow side tubes and upper and lowerarches (mouthguard). This way hollow front housing can be easilydetached from rest of the device after sleep to clean the mouthguard orwhen required such as repairing or replacement.

FIG. 11 depicts an exploded view of device as separate pieces which aresnap fitted together after manufactured. 1110 is front housing and 1120is inner mouth piece. 1111 is partial hollow tube and 1112 is base ofmouthguard. While 1113 is “boil and Bite” piece on top of base piece ofmouthguard 1112 for customization.

FIG. 12 depicts several manufacturing methods for device. Bothnon-customized and customized devices consist of two pieces A and B asshown below: front hollow housing 1210 (in which micro fan(s), sensors,microprocessors etc. are inserted after manufacturing); and an innermouth piece with hollow air passage way. The front housing hassnap/un-snap fit concept where front hollow housing section is easilysnap-fitted with inner mouth piece and also can be easily un-snapped(removed from inner piece).

The systems can be formed using the following methods. The front hollowhousing 1210 is made by injection molding. To prevent air leakagebetween hollow housing and inner mouth piece, an elastomeric ring ismounted on front housing or elastomeric ring is molded in one stepprocess as two shot injection molding. For the inner mouthpiece 1220,the following manufacturing methods are used to achieve predeterminedhollow passage ways. The inner mouth piece is divided into twoportions: 1. Partial hollow tube 1211 and 2. Base piece of Mouthguard1212 (upper or lower arch) A multi-step process can be used whichincludes separately injection mold partial hollow tube 1211 and basepiece of Mouthguard 1212 followed by bonding these two pieces to createhollow passage way in inner mouth piece 1220.

One can also make partial hollow tube 1211 and base piece of Mouthguard1212 by thermoforming process followed by bonding these two pieces tocreate hollow passage way in inner mouth piece 1220. Thermoformingprocess allows for customization. Bonding of these two pieces can bedone by ultrasonic welding, laser welding or mechanical bonding orcombinations of these technologies or adhesive bonding or other bondingtechnologies, creating the thin device with hollow side tubes. The wallthickness can be as low as 0.5 mm in several areas. One step injectionmolding process where partial walls of tube 1211 and base mouthguard1212 are molded in two cavities of a single mold, followed by rotatingcavities where two halves are aligned and second material 1213 isinjected at intersection, bonding these two pieces and creating hollowstructure. Here, the second material 1213 is soft material or same as“Boil and Bite” material 1213, creating customized oral device in asingle step process. (see FIG. 15). Water or gas injection molding toachieve hollow air passage way. Lastly, lost core foam injection moldingcan be used to for the passages.

Both non-customized and customized devices are manufactured by similarprocesses as described above except for customizations (to fit the teethperfectly) is achieved by processes such as 3D printing (hard orhard/soft materials), “boil and bite” concept and micro-cellular foaminginjection molding processes and thermoforming of a plastic sheet on atooth model. The device can be single piece construction, if it devicedoes not contain any sensors/microprocessor or sensors/microprocessorand battery are completely sealed, then no need to have snap-fitfeature. This single piece construction can be achieved by bonding oftwo separate injection molded halves at pre-determined line (orseparately injection molding hosing with partial tube and mouthguard)followed by bonding these two pieces to create hollow structure or bywater injection molding or by lost core foam injection molding. 3dprinting or additive manufacturing can be used to form the components orsingle piece device.

FIGS. 13A-13D depict a customized cross sections of the device using“Boil or Bite” concept to fit individual teeth. FIG. 13A and FIG. 13Bdepict portions of a device 134A, having both upper and lower arches1300, 1301 with hollow front housing 1310 and hollow side tubes 1315attached to upper arch 1300. FIG. 13C and FIG. 13D depict a device 134Bhaving upper arch 1300 only with hollow front housing 1310 and hollowside tubes 1315. Upper and lower arch portions touching the teeth aremade of material which will soften on boiling in water, due to glasstransition temperature of lower than 100 C and will form to the shape ofteeth upon biting in the mouth. The arch portions may be made of singlesoft material or soft and hard material. Soft material is used for “Boiland Bite” and hard material provides the support during bite. The hollowfront housing 1310 and hollow side tubes 1315 (and bottom of upper andlower arch portions) are made of high temperature plastics which do notsoften at all at 100 C (boiling point of water) due to their glasstransition temperature greater than 100 C. This way, after “Boiling andBiting” the device 134A, 134B, the individual can customize the deviceto fit his/her teeth and still air flow will not be affected as rest ofthe dimensions of device will not be changed during boiling and biting(hollow tubes and the hollow housing dimensions).

The “Boil and Bite” devices can be manufactured by two methods. 1.First, “Boil and Bite” soft portions of the upper and lower arches areinjection molded (or two-shot injection molded from soft/hard material)and this portion is inserted in a second tool where it is over-moldedwith high temperature plastics material forming rest of the part havinghollow side tubes and hollow front housing or 2. “Boil and bite”portions of upper and lower arches and rest of the device (hollow sidetubes and hollow front housing and bottom arch) are injection moldedseparately as shown in FIG. 13A or 13C, then mechanically snap-fitted tomake a single device shown in FIG. 13B or 13D. Later concept 2 may bebetter approach for individual since “Boil and Bite” portion requires tobe replaced every six months to preserve the bite. For individual, thesecond concept eliminates to buy whole unit, they must only buy a “boiland bite” portion, when needed, saving money.

FIGS. 14A-14D show a customized, single piece, micro oral PAP device 144manufactured by micro-cellular foaming injection molding. Device 144illustrates a concept for temporarily customizing device 144 duringsleep, allowing good grip by teeth and increasing comfort level. Asshown in FIG. 14A, a soft material 121 is used for the portion of thedevice 144 touching the teeth which is made out of microcellular foam1400. The microcellular foam 1404 can be open cell structure withregular elastomeric polymer or closed cell structure with highlyelastomeric material. Soft material 121 may alternatively comprisepolymeric gel material.

As shown in FIG. 14B, the individual inserts the device 144 in themouth, and upon biting on the device, the applied pressure deforms theelastomeric structure of microcellular foam 1404, allowing theimpression of teeth on the inside 1423 of the soft microcellular foam1404. This way, device 144 stays in place during sleep. To take device144 out from mouth upon waking up, the individual has to apply verticaldownward force on device 144. Once device 144 is removed from theindividual's mouth, the microcellular foam 1404 returns to its originalshape and is ready for the next night to again form a customized device.FIG. 14C shows device 144 with microcellular foam 1404, while FIG. 14Ddepicts cross section A-A of a portion of upper arch 1400 showing themicrocellular foam 1404 taking the shape of the individual's teeth afterbite.

FIG. 15 depict a single step manufacturing method for hollow device byinjecting material in two cavities, cavities rotation, followed byinjecting plastic at intersection of two halves, creating hollow part.

FIG. 16 depicts micro-holes in the hollow tube (or hollow passage way),blowing air at very low flow rate, but stimulating the tongue to stayforward original position (does not allow to fall back) during sleep.These micro-holes can be near the tongue (lingual area) FIG. 16 A and/orat the end of throat area (oropharynx area) as shown in FIG. 16B.

FIG. 16B depicts micro holes in the hollow tube at end connected to twoside tubes of an arch, directing the air flow at the end of oropharynx(directly at throat region). This can significantly help in keepingairway open compared to providing airflow by just two sides tubes.

FIG. 17 depicts special microchip embedded into mouthguard for nervestimulation. FIG. 18 depicts device as an impact sport guard withadditional airflow during play and protection of teeth. Energy absorbingand dissipation away from the teeth is achieved by selecting rightplastic material and internal design of the part wall like honeycomb orlattice like structure. This embodiment is referred to herein as apositive airway pressure impact sports guard with or withoutmicro-blower(s).

FIG. 19 depicts the device as a sleep apnea diagnostic device to detectOSA, having various sensors located in the hollow housing and/or themaxillary or mandibular arches which would be capable of measuring andrecording key data and proprietary algorithms providing AHI index whichcould be correlated to standard Sleep diagnostic tests such as PSG orPG.

Rigid or semi-rigid plastic examples suitable for use in manufacturingthe devices include, but are not limited to: Commodity thermoplasticssuch as polyvinyl chloride, polyolefin and polystyrene: polyvinylchloride having properties such as but not limited to: density of 1.2 to1.4 g/cc, tensile strength in range of 40 to 55 Mpa, tensile elongationin range of 20 to 100%, flexural modulus in range of 2.0 to 5 GPa;polyolefin such as polyethylene and polypropylene materials havingproperties such as but not limited to: density in range of 0.86 to 0.98g/cc, tensile strength in range of 20 to 60 Mpa, tensile elongation inrange of 50 to 150%, flexural modulus in range of 1.5 to 2.0 GPa,notched impact strength in range of 50 to 200 J/m; polycarbonate havingproperties such as but not limited to: density of 1.2 g/cc+/−0.1,tensile strength in range of 50 to 85 Mpa, tensile elongation in rangeof 40 to 140%, flexural modulus in range of 2.0 to 2.6 GPa, impactstrength in range of 300 to 1000 J/m; acrylics such as polymethylmethacrylate (PMMA), acrylic copolymers and acrylic multipolymer blendshaving properties such as but not limited to: density in range of 1.1 to1.2 g/cc, tensile strength in range of 30 to 75 Mpa, tensile elongationin range of 4 to 30%, flexural modulus in range of 1.5 to 4.0 GPa,notched impact strength in range of 100 to 300 J/m; Rigid thermoplasticspolyurethanes (TPU) can be polyester, polycarbonate or polyether basedTPU having properties such as but not limited to: density with the rangeof 1.05 g/cc to 1.20, shore D hardness of 35 D to 85 D, tensile strength@ break 35 to 70 MPa, tensile elongation in range of 50 to 300%,flexural modulus in range of 0.5 to 2.5 GPa; Polyesters including PBT orPET having properties such as but not limited to: density in range of1.2 to 1.4 g/cc, tensile strength @ break in range of 40 to 70 Mpa,tensile elongation in range of 40 to 100%, flexural modulus in range of2.0 to 3.5 GPa, notched impact strength in range of 35 to 70 J/m; ABShaving properties such as but not limited to: density in range of 1.00to 1.05 g/cc, tensile strength @ break in range of 30 to 50 Mpa, tensileelongation in range of 5 to 30%, flexural modulus in range of 2.0 to 3.0GPa, notched impact strength in range of 250 to 350 J/m; Nylons orpolyamides such as PA 6, PA 66, PA 11, PA 12, PA 46, PA 610, havingproperties such as but not limited to: density in range of 1.00 to 1.2g/cc, tensile strength @ break in range of 45 to 85 Mpa, tensileelongation in range of 30 to 200%, flexural modulus in range of 1.0 to3.0 GPa, notched impact strength in range of 25 to 120 J/m; Polyetherether ketone (PEEK) having properties such as but not limited to:density in range of 1.30 to 1.35 g/cc, tensile strength @ break in rangeof 90 to 150 Mpa, tensile elongation in range of 10 to 40%, flexuralmodulus in range of 4.0 to 4.5 GPa, notched impact strength in range of55 to 65 J/m; Composites of above plastics with glass fiber, carbonfiber and other fillers polymeric alloys comprising blends of polymerssuch as polycarbonate alloys with polybutylene terephthalate (PBT), andpolyethylene terephthalate (PET) for improved chemical resistance,PC/ABS copolymer alloys for ease of processability, PC/TPU, PC/ABS,PC/SMA, PBT/PET/ASA alloys, PA/TPU and several combinations of all theplastics described above; thermosets comprising photopolymers made outof methacrylated oligomers, monomers, acrylated monomers, low molecularweight polymers or elastomers to reduced brittleness having propertiessuch as but not limited to: density in range of 1.10 to 1.20 g/cc,tensile strength @ break in range of 40 to 65 Mpa, tensile elongation inrange of 10 to 40%, flexural modulus in range of 2.0 to 4.0 GPa, notchedimpact strength in range of 10 to 40 J/m and shore D hardness of 50 to80 D; Soft and elastomeric plastics include, but are not limited to:soft polyurethanes, EVA (ethylene vinyl acetate), TPE such as SEBS,elastomeric nylons, silicones elastomers, biopolymers (PLA—polylacticacid), thermoplastics or thermoset elastomers.

The devices can be formed of copolyester produced when more than onediacid or diol is used in the polyester polymerization process, such asPETG (polyethylene terephthalate glycol), PCTG (Polycyclohexylenedimethylene terephthalate glycol) with properties such as but notlimited to: density in range of 1.2 to 1.7 g/cc, tensile strength @break in range of 25 to 30 Mpa, Tensile elongation in range of 110 to300%, flexural modulus in range of 1.8 to 2.2 GPa, notched impactstrength in range of 100 J/m to no break; soft polyurethanes (TPUelastomers) having properties such as but not limited to: density withthe range of 1.05 g/cc to 1.30, shore D hardness of 30 D to 75 D,tensile strength @ break 15 to 50 MPa, tensile elongation in range of300 to 800%, flexural modulus in range of 0.03 to 0.15 GPa. compressionset 10 to 45%, tear strength 80 to 180 N/mm; EVA (ethylene vinylacetate) having properties such as but not limited to: density with therange of 0.93 g/cc to 0.96 g/cc, shore D hardness of 30 D to 50 D,tensile strength @ break 3 to 35 MPa, tensile elongation in range of 300to 800%, elastic modulus in range of 0.015 to 0.08 GPa; and siliconeselastomers having properties such as but not limited to: density withthe range of 1.12 g/cc to 1.2 g/cc, shore A hardness of 30 A to 70 A,tensile strength @ break 8 to 15 MPa, tensile elongation in range of 300to 800%, compression set 10 to 20%, tear strength 30 to 40 N/mm.

Additionally, the material can be formed of TPE such as SEBS havingproperties such as but not limited to: density with the range of 1.15g/cc to 1.25 g/cc, shore D hardness of 35 D to 75 D, tensile strength @break 10 to 45 MPa, tensile elongation in range of 200 to 375%,compression set 5 to 30%, tear strength 80 to 100 N/mm. Polymericmaterials can also be blended with fillers such as carbon fibers, carbonnanotubes, glass microsphere, silica, etc., to obtain the desiredproperties of a mouth guard.

The invention relates to oral or nasal or a combination of oral andnasal sleep apnea diagnostic device as Home Sleep Testing (HST) devicefor the diagnosis of obstructive sleep apnea (OSA) and snoring; havingmicroprocessors and sensors, comprising of following configurations: 1)Basic HST unit for standard OSA testing. This configuration withoutmandibular advancement (MAD) can be provided with upper mouth piece only(i.e. without the lower mouth piece) or with lower mouth piece only(i.e. without the upper mouth piece); 2) HST unit with mandibularadvancement (MAD)—this is to validate specific mandibular advancementsetting and treatment of sleep apnea with or without innovative oralCPAP sleep apnea device or current CPAP device; 3) HST unit to be usedin conjunction with current CPAP for determining the efficacy of apressure setting; 4) HST device as sleep apnea diagnostic as well astreatment device: In addition to device performing as diagnostic tool(as Home Sleep Testing (HST) or Out of center Sleep Testing (OOCST) fordetecting OSA, the same device can also be used as sleep apnea treatmentand/or anti-snoring device.

The device can be fitted with a mix of sensors to measure air flow; SpO2(oxygen saturation in blood), heart rate (beats/min) and respiratoryeffort. These parameters would be sufficient to perform a sleep studyconforming to the guidelines by CMS or AASM for a Type III or Type iVstudy. Additional sensors can be included to measure temperature; bodypositions while at sleep, Sound (breathing) variation and snoring,Single channel ECG (heart), EEG for brain activity etc. Actual sleeptime is not measured by current HST devices while in one embodiment thedevice can have built-in sensors or wirelessly communicating sensorslike heart rate, breathing monitoring, position sensor for body movementduring sleep, temperature along with proprietary algorithm helps inmeasuring actual (true) sleep time which is very important for accurate(true) AHI number, a measure of severity of sleep apnea.

In one embodiment, the device would be fitted with a differentialpressure sensor to measure airflow and pressure (or alternately with aPVDF calibrated strip), a novel pulse ox sensor from lips for oxygensaturation and heart rate (alternately could be a standard pulseoximeter with Bluetooth capability), and a photophlethysmographic (PPG)sensor to measure respiratory effort (alternately could be a standardRIP belt to acquire the same parameter).

All these parameters can be continuously acquired and stored on a memorySD card built into the unit (device) or wirelessly transferred usingBluetooth, wifi, cloud or other similar technologies to a mobile deviceor to cloud based server. This data can then be analyzed by automatedcomputer algorithms for episodes of breathing irregularities whilesleeping—such as apneaic or hypopneaic events and summarized to provideAHI/RDI information. The RDI is defined as the average number ofrespiratory disturbances. The device can be controlled wirelessly usingmobile devices.

In another embodiment, the device can be enhanced by addition of soundsensor to measure breathing patterns and snoring variation, thermistorfor temperature of air flow and breathing pattern, miniature videocamera mounted on the mouthguard to take pictures of inside of mouthduring sleep and a processing unit to capture and analyze theseparameters to provide a far more comprehensive sleep study reportcompared to a Type III or Type IV HST device.

Both of above embodiments can be adapted to validate MandibularAdjustment (MAD) setting by providing oral component with mandibularadjustments (lower jaw advancement) in specific fine increments. Alsothe device of present invention can be concurrently used with CPAP andvalidate efficacy of pressure setting for the CPAP treatment.

The foregoing description is merely illustrative in nature and is in noway intended to limit the disclosure, its application, or uses. Thebroad teachings of the disclosure can be implemented in a variety offorms. Therefore, while this disclosure includes particular examples,the true scope of the disclosure should not be so limited since othermodifications will become apparent upon a study of the drawings, thespecification, and the following claims. It should be understood thatone or more steps within a method may be executed in different order (orconcurrently) without altering the principles of the present disclosure.Further, although each of the embodiments is described above as havingcertain features, any one or more of those features described withrespect to any embodiment of the disclosure can be implemented in and/orcombined with features of any of the other embodiments, even if thatcombination is not explicitly described. In other words, the describedembodiments are not mutually exclusive, and permutations of one or moreembodiments with one another remain within the scope of this disclosure.

Spatial and functional relationships between elements (for example,between modules) are described using various terms, including“connected,” “engaged,” “interfaced,” and “coupled.” Unless explicitlydescribed as being “direct,” when a relationship between first andsecond elements is described in the above disclosure, that relationshipencompasses a direct relationship where no other intervening elementsare present between the first and second elements, and also an indirectrelationship where one or more intervening elements are present (eitherspatially or functionally) between the first and second elements. Asused herein, the phrase at least one of A, B, and C should be construedto mean a logical (A OR B OR C), using a non-exclusive logical OR, andshould not be construed to mean “at least one of A, at least one of B,and at least one of C.”

In the figures, the direction of an arrow, as indicated by thearrowhead, generally demonstrates the flow of information (such as dataor instructions) that is of interest to the illustration. For example,when element A and element B exchange a variety of information butinformation transmitted from element A to element B is relevant to theillustration, the arrow may point from element A to element B. Thisunidirectional arrow does not imply that no other information istransmitted from element B to element A. Further, for information sentfrom element A to element B, element B may send requests for, or receiptacknowledgements of, the information to element A.

In this application, including the definitions below, the term ‘module’or the term ‘controller’ may be replaced with the term ‘circuit.’ Theterm ‘module’ may refer to, be part of, or include processor hardware(shared, dedicated, or group) that executes code and memory hardware(shared, dedicated, or group) that stores code executed by the processorhardware.

The module may include one or more interface circuits. In some examples,the interface circuits may include wired or wireless interfaces that areconnected to a local area network (LAN), the Internet, a wide areanetwork (WAN), or combinations thereof. The functionality of any givenmodule of the present disclosure may be distributed among multiplemodules that are connected via interface circuits. For example, multiplemodules may allow load balancing. In a further example, a server (alsoknown as remote, or cloud) module may accomplish some functionality onbehalf of a client module.

The term code, as used above, may include software, firmware, and/ormicrocode, and may refer to programs, routines, functions, classes, datastructures, and/or objects. Shared processor hardware encompasses asingle microprocessor that executes some or all code from multiplemodules. Group processor hardware encompasses a microprocessor that, incombination with additional microprocessors, executes some or all codefrom one or more modules. References to multiple microprocessorsencompass multiple microprocessors on discrete dies, multiplemicroprocessors on a single die, multiple cores of a singlemicroprocessor, multiple threads of a single microprocessor, or acombination of the above.

Shared memory hardware encompasses a single memory device that storessome or all code from multiple modules. Group memory hardwareencompasses a memory device that, in combination with other memorydevices, stores some or all code from one or more modules.

The term memory hardware is a subset of the term computer-readablemedium. The term computer-readable medium, as used herein, does notencompass transitory electrical or electromagnetic signals propagatingthrough a medium (such as on a carrier wave); the term computer-readablemedium is therefore considered tangible and non-transitory. Non-limitingexamples of a non-transitory computer-readable medium are nonvolatilememory devices (such as a flash memory device, an erasable programmableread-only memory device, or a mask read-only memory device), volatilememory devices (such as a static random access memory device or adynamic random access memory device), magnetic storage media (such as ananalog or digital magnetic tape or a hard disk drive), and opticalstorage media (such as a CD, a DVD, or a Blu-ray Disc).

The apparatuses and methods described in this application may bepartially or fully implemented by a special purpose computer created byconfiguring a general purpose computer to execute one or more particularfunctions embodied in computer programs. The functional blocks andflowchart elements described above serve as software specifications,which can be translated into the computer programs by the routine workof a skilled technician or programmer.

The computer programs include processor-executable instructions that arestored on at least one non-transitory computer-readable medium. Thecomputer programs may also include or rely on stored data. The computerprograms may encompass a basic input/output system (BIOS) that interactswith hardware of the special purpose computer, device drivers thatinteract with particular devices of the special purpose computer, one ormore operating systems, user applications, background services,background applications, etc.

The computer programs may include: (i) descriptive text to be parsed,such as HTML (hypertext markup language), XML (extensible markuplanguage), or JSON (JavaScript Object Notation) (ii) assembly code,(iii) object code generated from source code by a compiler, (iv) sourcecode for execution by an interpreter, (v) source code for compilationand execution by a just-in-time compiler, etc. As examples only, sourcecode may be written using syntax from languages including C, C++, C#,Objective-C, Swift, Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl,Pascal, Curl, OCaml, Javascript®, HTML5 (Hypertext Markup Language 5threvision), Ada, ASP (Active Server Pages), PHP (PHP: HypertextPreprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, VisualBasic®, Lua, MATLAB, SIMULINK, and Python®.

None of the elements recited in the claims are intended to be ameans-plus-function element within the meaning of 35 U.S.C. § 112(f)unless an element is expressly recited using the phrase “means for” or,in the case of a method claim, using the phrases “operation for” or“step for.”

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail.

The terminology used herein is for the purpose of describing particularexample embodiments only and is not intended to be limiting. As usedherein, the singular forms “a,” “an,” and “the” may be intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. The terms “comprises,” “comprising,” “including,” and“having,” are inclusive and therefore specify the presence of statedfeatures, integers, steps, operations, elements, and/or components, butdo not preclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. The method steps, processes, and operations described hereinare not to be construed as necessarily requiring their performance inthe particular order discussed or illustrated, unless specificallyidentified as an order of performance. It is also to be understood thatadditional or alternative steps may be employed.

When an element or layer is referred to as being “on,” “engaged to,”“connected to,” or “coupled to” another element or layer, it may bedirectly on, engaged, connected or coupled to the other element orlayer, or intervening elements or layers may be present. In contrast,when an element is referred to as being “directly on,” “directly engagedto,” “directly connected to,” or “directly coupled to” another elementor layer, there may be no intervening elements or layers present. Otherwords used to describe the relationship between elements should beinterpreted in a like fashion (e.g., “between” versus “directlybetween,” “adjacent” versus “directly adjacent,” etc.). As used herein,the term “and/or” includes any and all combinations of one or more ofthe associated listed items.

Although the terms first, second, third, etc. may be used herein todescribe various elements, components, regions, layers and/or sections,these elements, components, regions, layers and/or sections should notbe limited by these terms. These terms may be only used to distinguishone element, component, region, layer or section from another region,layer or section. Terms such as “first,” “second,” and other numericalterms when used herein do not imply a sequence or order unless clearlyindicated by the context. Thus, a first element, component, region,layer or section discussed below could be termed a second element,component, region, layer or section without departing from the teachingsof the example embodiments.

Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,”“lower,” “above,” “upper,” and the like, may be used herein for ease ofdescription to describe one element or feature's relationship to anotherelement(s) or feature(s) as illustrated in the figures. Spatiallyrelative terms may be intended to encompass different orientations ofthe device in use or operation in addition to the orientation depictedin the figures. For example, if the device in the figures is turnedover, elements described as “below” or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.Thus, the example term “below” can encompass both an orientation ofabove and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein interpreted accordingly.

In the foregoing description, the teachings have been described withreference to specific exemplary embodiments thereof. It will be apparentto those skilled in the art that a person understanding these teachingsmay conceive of changes or other embodiments or variations, whichutilize the principles of this teachings without departing from thebroader spirit and scope of the teachings. The specification anddrawings are, therefore, to be regarded in an illustrative rather than arestrictive sense.

What is claimed is:
 1. An oral sleep apnea treatment device selectivelyengagable with a patient's lips and teeth, said oral sleep apneatreatment device comprising: a front hollow housing defining a firstthrough passage, said front hollow housing having an exterior surfaceconfigured to engage the patient's lips; a mouthpiece having an exteriorsurface defining a tooth engaging surface and defining second and thirdthrough passages, each defining an aperture disposed adjacent to theadjacent to the retromolar pad members when engaged with the patient'steeth, the front hollow housing being selectively engageable to themouthpiece; and one of a pressure generating device and an air flowgenerating device disposed within the first through passage, thegenerating device configured to create an airflow through the second andthird passage and adjacent the retromolar pad members.
 2. The device ofclaim 1, wherein the device comprises a battery disposed within thefront hollow housing, said battery being electrically coupled to thegenerating device.
 3. The device of claim 1, wherein the devicecomprises a controller configured to regulate electrical power suppliedto the generating device.
 4. The device of claim 1, wherein themouthpiece is formed using one of additive manufacturing, injectionmolding, thermoforming and blow molding.
 5. The device of claim 4wherein the mouthpiece is injection over-molding with an elasticallydeformable, low durometer material.
 6. The device of claim 1, whereinthe mouthpiece defines an aperture configured to project moving air ontoan oropharynx area of the patient.
 7. The device of claim 1, furthercomprising first and second members having member defining a u-shape,said first and second members defining the defining second and thirdthrough passages, and a plurality of flanges disposed between the firstand second members and said plurality of flanges engaging a tongue. 8.The device of claim 1, the mouth piece comprises first and second ushaped components, the first and second u-shaped members defining thesecond and third through passages.
 9. The device of claim 8, wherein theplurality of sensors comprise at least one of a pressure sensor, anairflow sensor, temperature sensors, sound sensor, an accelerometer, anda pulse oximeter.
 10. The device of claim 8, wherein the control modulecomprises one of a closed loop control system and a wirelesscommunication module.
 11. The device of claim 1, further comprising acontrol module in the front hollow housing, wherein the control moduleis coupled to a plurality of sensors, the control module configured toprovide a signal to control operation of the generating device.
 12. Thedevice of claim 1 further comprising a mandibular advancement device.13. The device of claim 1 further comprising a nostril tubes inconnection to the front hollow housing to a nasal passage.
 14. An oralsleep apnea treatment device selectively engagable with a patient's lipsand teeth, said oral sleep apnea treatment device comprising: a fronthollow housing defining a first through passage, said front hollowhousing having an exterior surface configured to engage the patient'slips; a mouthpiece having an exterior surface defining a tooth engagingsurface and defining second and third through passages, each defining aplurality of apertures disposed adjacent to soft tissues within thepatient's mouth when engaged with the patient's teeth, the front hollowhousing being selectively engageable to the mouthpiece; and a blowerdisposed within the first through passage, the blower configured tocreate an airflow through the second and third passage and onto thepatient's soft tissue.
 15. The device of claim 14 further comprisingelectrodes configured to engage the soft palates and tongue.
 16. Thedevice of claim 14 further comprising a tilt sensor configured and afeedback mechanism, the feedback mechanism configured to wake thepatient when the patient is not sleeping on a patient's side.
 17. Thedevice of claim 14 wherein the mouthpiece a boil and bite material. 18.The device of claim 14 wherein the plurality of apertures disposedadjacent to soft tissues within the patient's mouth are configured toblow air at very low flow rate, the micro-holes positioned adjacent apatients lingual area.
 19. The device of claim 14 comprising acontroller and a plurality of sensors disposed within in the fronthollow housing, the controller being configured to calculate an AHIindex.
 20. The device of claim 19, wherein the plurality of sensorscomprise one of a pressure sensor, an airflow sensor and one or moretemperature sensors, sound sensor, tilt sensor, and a pulse oximeter.